Medical Device Manufacturer · US , Bolton , MA

Apple Medical Corp. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 1994

Recent clearances: FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158, APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR, APPLE MEDICAL OB MOBIUS ELASTIC RETRACTOR

Total

Cleared

Denied

Apple Medical Corp. has 9 FDA 510(k) cleared medical devices. Based in Bolton, US.

Historical record: 9 cleared submissions from 1994 to 2006.

Browse the FDA 510(k) cleared devices submitted by Apple Medical Corp. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Citech as regulatory consultant.

Apple Medical Corp. is one of 15083 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Apple Medical Corp.

9 devices

1-9 of 9

Cleared Oct 20, 2006

FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158

K061651 · HGI

Obstetrics & Gynecology · 129d

Cleared Apr 26, 2005

APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR

K050256 · GAD

General & Plastic Surgery · 82d

Cleared May 13, 2004

APPLE MEDICAL OB MOBIUS ELASTIC RETRACTOR

K041131 · GCJ

General & Plastic Surgery · 13d

Cleared Feb 15, 2002

APPLE MEDICAL MOBIUS ELASTIC RETRACTOR

K014005 · GCJ

General & Plastic Surgery · 72d

Cleared Mar 31, 2000

APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER

K000026 · HHK

Obstetrics & Gynecology · 86d

Cleared Mar 27, 1997

PNEUMO-MATIC INSUFFLATION NEEDLE

K970788 · FHO

Gastroenterology & Urology · 23d

Cleared Nov 19, 1996

LWEET CONE BIOPSY INSTRUMENT

K961460 · HGI

Obstetrics & Gynecology · 217d

Cleared Aug 18, 1995

THE ASSISTANT

K952841 · FHA

Gastroenterology & Urology · 58d

Cleared Oct 05, 1994

URETERAL ILLUMINATOR

K941506 · FCS

Gastroenterology & Urology · 190d

Apple Medical Corp. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Apple Medical Corp.

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