Apple Medical Corp.
United StatesFDA applicant, unverified
- Devices
- 9
- FDA recalls
- 8
At a glance
Market reach
- United States
- FDA recalls
What Apple Medical Corp. makes
Apple Medical Corp. manufactures surgical instruments including elastic retractors, cone biopsy instruments, uterine samplers, insufflation needles, and a ureteral illuminator.
The company's products are listed in the FDA 510(k) registry and include Class I and Class II devices. Apple Medical Corp. is based in the US.
Catalogue
Apple Medical Ob Mobius Elastic Retractor Ref K041131
Regimes: 510(k) Registry: 510(k)Lweet Cone Biopsy Instrument Ref K961460
Regimes: 510(k) Registry: 510(k)Apple Medical Mobius Elastic Retractor Ref K014005
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Apple Medical/Ob Mobius Elastic Retractor Ref K050256
Regimes: 510(k) Registry: 510(k)The Assistant Ref K952841
Regimes: 510(k) Registry: 510(k)Pneumo-Matic Insufflation Needle Ref K970788
Regimes: 510(k) Registry: 510(k)Apple Medical One-Touch Uterine Sampler Ref K000026
Regimes: 510(k) Registry: 510(k)Ureteral Illuminator Ref K941506
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 8 recalls initiated by Apple Medical Corp., initiated on 2006-03-10. By recorded status: 8 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2006
- 10 Mar 2006 Z-0614-06 Unclassified (pre-2012) Terminated Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient.
Full distribution text
- 10 Mar 2006 Z-0615-06 Unclassified (pre-2012) Terminated Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient.
Full distribution text
- 10 Mar 2006 Z-0616-06 Unclassified (pre-2012) Terminated Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient.
Full distribution text
- 10 Mar 2006 Z-0617-06 Unclassified (pre-2012) Terminated Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient.
Full distribution text
- 10 Mar 2006 Z-0618-06 Unclassified (pre-2012) Terminated Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient.
Full distribution text
- 10 Mar 2006 Z-0619-06 Unclassified (pre-2012) Terminated Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient.
Full distribution text
- 10 Mar 2006 Z-0620-06 Unclassified (pre-2012) Terminated Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient.
Full distribution text
- 10 Mar 2006 Z-0621-06 Unclassified (pre-2012) Terminated Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient.
Full distribution text
- 10 Mar 2006 Z-0614-06 Unclassified (pre-2012) Terminated Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient.
Frequently asked questions
How many devices does Apple Medical Corp. have in the registry?
The registry currently lists 9 devices for Apple Medical Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Apple Medical Corp.'s devices?
Among its 9 most recently registered devices, Apple Medical Corp. has devices listed in FDA 510(k) (9 devices).
What risk classes do Apple Medical Corp.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Apple Medical Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Apple Medical Corp.?
FDA recall records list 8 recalls initiated by Apple Medical Corp., the most recent initiated on 10 Mar 2006. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Apple Medical Corp. in the registry?
The most recently registered devices listed for Apple Medical Corp. include APPLE MEDICAL OB MOBIUS ELASTIC RETRACTOR, LWEET CONE BIOPSY INSTRUMENT, APPLE MEDICAL MOBIUS ELASTIC RETRACTOR and FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158.