FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
114289–114312 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 04, 1993
ARTHREX BAYONET KNIFE
K925457 · HRX
Arthrex, Inc.
Orthopedic · 128d
Cleared Mar 04, 1993
ARTHREX RING CURETTE
K925458 · HRX
Arthrex, Inc.
Orthopedic · 127d
Cleared Mar 04, 1993
SEIDEL HUMERAL LOCKING NAIL & ADDITIONAL LENGTHS
K925544 · HSB
Howmedica Corp.
Orthopedic · 135d
Cleared Mar 04, 1993
ARTHREX INSTRUMENTS (BASIC)
K925814 · HRX
Arthrex, Inc.
Orthopedic · 107d
Cleared Mar 04, 1993
ARTHROSCOPIC RETRACTORS AND GRASPERS
K925884 · HRX
Arthrex, Inc.
Orthopedic · 105d
Cleared Mar 04, 1993
WALL BUCKY HOLDERS LT. & RT. HAND, & CENTER MOUNT
K925934 · IXY
Continental X-Ray Corp.
Radiology · 104d
Cleared Mar 04, 1993
ARTHREX INSTRUMENTS (BASIC)
K925954 · HRX
Arthrex, Inc.
Orthopedic · 100d
Cleared Mar 04, 1993
ARTHROSCOPIC ACL DRILL SYSTEM
K925986 · HRX
Arthrex, Inc.
Orthopedic · 99d
Cleared Mar 04, 1993
ARTHREX INSTRUMENTS (KNEE, GP 3)
K925995 · HRX
Arthrex, Inc.
Orthopedic · 97d
Cleared Mar 04, 1993
BACTEC PEDS PLUS/F
K926304 · MDB
Bd Becton Dickinson Vacutainer...
Microbiology · 79d
Cleared Mar 04, 1993
AUDIOSCAN
K926336 · EWO
Electrocaine Medical System
Ear, Nose, Throat · 78d
Cleared Mar 04, 1993
KODAK X-OMATIC IDENTIFICATION CAMERA, MODEL 4 & 4L
K926404 · JAC
Eastman Kodak Company
Radiology · 73d
Cleared Mar 04, 1993
QUANTA LITE(TM) JO-1 ELISA KIT
K926562 · LLL
Inova Diagnostics, Inc.
Immunology · 63d
Cleared Mar 04, 1993
OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP
K930185 · CEP
Princeton Biomedix
Chemistry · 49d
Cleared Mar 03, 1993
VARIOUS UTILITY/SURGICAL DRAPE, STERILE, DISPOSABL
K920346 · KKX
Trinity Laboratories, Inc.
General Hospital · 401d
Cleared Mar 03, 1993
PRIMEDIC DEFIBRILLATORS-N/B
K921765 · LDD
Metronic Electronic GmbH
Cardiovascular · 323d
Cleared Mar 03, 1993
DISPOSABLE CYSTOSCOPY SPLASH DRAPE-STERILE #599
K922059 · KKX
Graham Medical Products
General Hospital · 309d
Cleared Mar 03, 1993
MORSE(R) ANGIOGRAPHIC CATHETERS
K922552 · DQO
North American Instrument Corp.
Cardiovascular · 278d
Cleared Mar 03, 1993
LAPAROSCOPIC SURGICAL INSTRUMENTS
K923820 · GCJ
Microcut, Inc.
General & Plastic Surgery · 216d
Cleared Mar 03, 1993
CHOLANGIOGRAPHY CLAMP
K924480 · GBZ
Applied Medical Resources
General & Plastic Surgery · 181d
Cleared Mar 03, 1993
STERLING LATEX EXAM GLOVE, HYPO-ALLERGENIC
K924959 · LYY
Perlink USA, Inc.
General Hospital · 154d
Cleared Mar 03, 1993
KOTEX(R) SECUREHOLD SUPER CURVE/CURVED MAXI PADS
K925250 · HHD
Kimberly-Clark Corp.
Obstetrics & Gynecology · 138d
Cleared Mar 03, 1993
IV FLUID TRANSFER PIN
K925401 · LHI
B. Braun of America, Inc.
General Hospital · 128d
Cleared Mar 03, 1993
DRITRAINER
K930005 · KPN
Laborie Medical Technologies, Ltd.
Gastroenterology & Urology · 58d