FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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 · Free access · No registration required

Filters: Cleared only ×
175,820 results
122665–122688 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 29, 1991
NONSTAINING ALASTIKS
K910288 · EJF
Unitek Corp.
Dental · 66d
Cleared Mar 29, 1991
PARAMAX(R) ELECTROLYTE CALIBRATOR 1&2/MODIFICATION
K910309 · JIX
Baxter Healthcare Corp
Chemistry · 64d
Cleared Mar 29, 1991
DU PONT IDENTIFICATION CAMERA
K910354 · JAC
Dupont Medical Products
Radiology · 59d
Cleared Mar 29, 1991
GESCO PER-Q-CATH REPAIR KIT
K910622 · LJS
Gesco Intl., Inc.
General Hospital · 45d
Cleared Mar 29, 1991
ALL BOND LINER-F
K910628 · KLE
Bisco, Inc.
Dental · 64d
Cleared Mar 29, 1991
BIO SCAN-BG(TM
K910692 · CGA
Bio Scan Instrument, Inc.
Chemistry · 38d
Cleared Mar 29, 1991
AMPRO SURGEON'S GLOVES
K910711 · KGO
American Pro Latex, Inc.
General Hospital · 37d
Cleared Mar 29, 1991
LIGHT-TOUCH AND SURGI LIGHT FIBERS
K910726 · GEX
Lifestream Int'L, Inc.
General & Plastic Surgery · 37d
Cleared Mar 29, 1991
STREPTEX ACID EXTRACTION KIT
K910797 · GTZ
Wellcome Diagnostics
Microbiology · 31d
Cleared Mar 29, 1991
LAPAROFLATOR ELECTRONIC 3509
K910883 · HIF
F.M. Wiest USA, Inc.
Obstetrics & Gynecology · 28d
Cleared Mar 29, 1991
CHOLESTEROL CALIBRATOR SET
K910962 · JIT
Casco Standards
Chemistry · 23d
Cleared Mar 29, 1991
GSI 37 AUTO TYMP
K911095 · ETY
Lucas Grason-Stadler, Inc.
Ear, Nose, Throat · 16d
Cleared Mar 29, 1991
MICRO SCISSORS, 5MM CURVE MICRO SCISSORS, 5MM
K911158 · LRW
Northgate Technologies, Inc.
General & Plastic Surgery · 14d
Cleared Mar 29, 1991
PALPATION PROBE
K911159 · GEN
Northgate Technologies, Inc.
General & Plastic Surgery · 14d
Cleared Mar 29, 1991
CLAW (5MM/10MM) ATRAUMATIC GRASP/MICRO FORCEPS
K911180 · HTD
Northgate Technologies, Inc.
General & Plastic Surgery · 11d
Cleared Mar 29, 1991
YOURS TRULY ASYMMETRICAL BREAST FORM
K911247 · KCZ
Jobst Institute, Inc.
General & Plastic Surgery · 8d
Cleared Mar 28, 1991
SWIRL PROPHYLAXIS PASTE
K903986 · EJR
Bio-Medica Concepts
Dental · 211d
Cleared Mar 28, 1991
TRIMEDYNE MODEL 1210 OMNIPULSE LASER SYSTEM
K905708 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 97d
Cleared Mar 28, 1991
MEGA DRESSING CHANGE KIT
K910363 · MCY
Megadyne Medical Products, Inc.
General & Plastic Surgery · 58d
Cleared Mar 28, 1991
WOUND CLOSURE KIT
K910365 · LRO
Megadyne Medical Products, Inc.
General & Plastic Surgery · 58d
Cleared Mar 28, 1991
MEGA GENERAL PURPOSE INSTRUMENT KIT
K910366 · KDD
Megadyne Medical Products, Inc.
General & Plastic Surgery · 58d
Cleared Mar 28, 1991
INCISION AND DRAINAGE KIT
K910369 · KDD
Megadyne Medical Products, Inc.
General & Plastic Surgery · 58d
Cleared Mar 28, 1991
AVD INTIMAX CHOLANGIOGRAPHY CATHETER
K910493 · FGE
Applied Vascular Devices, Inc.
Gastroenterology & Urology · 51d
Cleared Mar 28, 1991
SURGICAL CLIPPER
K910524 · LWK
Baxter Healthcare Corp
General & Plastic Surgery · 49d