FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: General & Plastic Surgery ×
18,327 results
11065–11088 of 18,327
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Aug 11, 1995
PREPERITONEAL DISTENTION BALLOON SYSTEMS (MODIFICATION)
K953561 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 28d
Cleared Aug 09, 1995
ACU-HALT
K945374 · LDQ
Eva-Health USA, Inc.
General & Plastic Surgery · 280d
Cleared Aug 09, 1995
KARL STORZ ENDOSCOPY POWDER BLOWER
K952443 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 76d
Cleared Aug 08, 1995
STRYKER COMMAND2 OFFICE CONSOLE
K953071 · JEA
Stryker Instruments
General & Plastic Surgery · 39d
Cleared Aug 07, 1995
PERSONAL ALARM SYSTEM (PAS)
K944961 · LDQ
Cytoprobe Corp.
General & Plastic Surgery · 304d
Cleared Aug 07, 1995
PHOTODERM VL.
K950493 · GEX
Esc, Energy Systems Corp.
General & Plastic Surgery · 182d
Cleared Aug 07, 1995
ELMER
K952118 · GEX
Biological Technology Corp.
General & Plastic Surgery · 94d
Cleared Aug 07, 1995
THE REUSABLE SPACEMAKER SURGICAL BALLOON DISSECTOR & CANNULA
K952278 · GCJ
General Surgical Innovations
General & Plastic Surgery · 84d
Cleared Aug 07, 1995
SPACEMAKER SURGICAL BALLOON DISSECTOR WITH CANNULA & THE SPACEMAKER II...
K952444 · GCJ
Adjacent Surgical, Inc.
General & Plastic Surgery · 74d
Cleared Aug 07, 1995
TRANSAN, TRANSPARENT FILM DRESSING, TRANSPARENT WOUND DRSSING
K952449 · MGP
Medical Device Development Co.
General & Plastic Surgery · 74d
Cleared Aug 07, 1995
SILON SILICONE TEXTILE COMPOSITE
K952546 · MDA
Bio Med Sciences, Inc.
General & Plastic Surgery · 66d
Cleared Aug 07, 1995
EX-111 WOUND DRESSING
K952907 · FRO
Variseal Manufacturing Corp.
General & Plastic Surgery · 46d
Cleared Aug 07, 1995
BIOACCESS MARROW HARVEST SYSTEM
K953064 · GDM
Bioaccess, Inc.
General & Plastic Surgery · 38d
Cleared Aug 07, 1995
CURASOL GEL WOUND DRESSING
K953450 · MGQ
Dpt Laboratories, Ltd.
General & Plastic Surgery · 20d
Cleared Jul 31, 1995
AEROS ASPIRATOR
K952103 · BTA
Aeros Instruments, Inc.
General & Plastic Surgery · 88d
Cleared Jul 31, 1995
OTOSILK
K952203 · NAD
Boston Medical Products, Inc.
General & Plastic Surgery · 82d
Cleared Jul 31, 1995
MEDLITE LASER SYSTEM
K952636 · GEX
Continuum Biomedical, Inc.
General & Plastic Surgery · 53d
Cleared Jul 31, 1995
SIDEFIRE - TIPPED REUSABLE OPTICAL FIBERS
K952733 · GEX
Myriad Lase, Inc.
General & Plastic Surgery · 46d
Cleared Jul 31, 1995
SACS, INDEPENDENT FIBER COOLANT SYSTEM
K952754 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 46d
Cleared Jul 31, 1995
ENDOPATH* TRISTAR FLAT BLADED SURGICAL OBTURATOR & SLEEVE
K952842 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 40d
Cleared Jul 31, 1995
QUESTUS DISPOSABLE ENDOSCOPIC KNIFE
K952926 · GCJ
Wrightmedicaltechnologyinc
General & Plastic Surgery · 35d
Cleared Jul 28, 1995
ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESS
K944947 · GEI
Boston Surgical Products, Inc.
General & Plastic Surgery · 294d
Cleared Jul 26, 1995
KARL STORZ DRILL
K952008 · GEY
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 89d
Cleared Jul 26, 1995
BURNSHIELD TRAUMA DRESSING
K952247 · MGQ
Golightly International Corp.
General & Plastic Surgery · 76d