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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
90121–90144 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 24, 1998
DIRECT BILIRUBIN (DBIL)
K981222 · CIG
Abbott Laboratories
Chemistry · 21d
Cleared Apr 24, 1998
ELECSYS CALCHECK FERRITIN
K981281 · JJX
Roche Diagnostics GmbH
Chemistry · 16d
Cleared Apr 24, 1998
DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109
K981436 · JIX
Casco Standards
Chemistry · 10d
Cleared Apr 23, 1998
STERITEC DISPOSABLE INTEGRATOR LOAD CHALLENGE-STEAM
K965212 · JOJ
Steritec Products Mfg Co, Inc.
General Hospital · 482d
Cleared Apr 23, 1998
COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
K974424 · LYY
Comfort Rubber Gloves Industries Sdn....
General Hospital · 150d
Cleared Apr 23, 1998
CS/3 ARRHYTHMIA WORKSTATION
K974747 · DSI
Datex-Engstrom, Inc.
Cardiovascular · 125d
Cleared Apr 23, 1998
SERAQUEST MUMPS IGG
K980059 · LJY
Quest Intl., Inc.
Microbiology · 106d
Cleared Apr 23, 1998
MANAN GALACTOGRAPHY KIT
K980227 · FMI
Medical Device Technologies, Inc.
General Hospital · 91d
Cleared Apr 23, 1998
THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K980376 · LTJ
Bayer Corp.
Immunology · 83d
Cleared Apr 23, 1998
PROSPECT SHIGA TOXIN MICROPLATE ASSAY
K980507 · GMZ
Alexon - Trend, Inc.
Microbiology · 72d
Cleared Apr 23, 1998
REGENT BIOGEL ORTHOPEDIC SURGICAL GLOVE
K980516 · KGO
London International Group, Inc.
General Hospital · 72d
Cleared Apr 23, 1998
DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM
K980759 · LLL
Diamedix Corp.
Immunology · 55d
Cleared Apr 23, 1998
POWDER FREE CHLORINATED GLOVES-(TEXTURED)
K981164 · LYY
Pan-Century Rubber Products Sdn. Bhd.
General Hospital · 23d
Cleared Apr 23, 1998
ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED)
K981221 · CIT
Abbott Laboratories
Chemistry · 20d
Cleared Apr 23, 1998
ASPARTATE AMINOTRANSFERASE (AST)
K981225 · CIT
Abbott Laboratories
Chemistry · 20d
Cleared Apr 23, 1998
ELECSYS CALCHECK CA 125II
K981278 · JJX
Roche Diagnostics GmbH
Chemistry · 15d
Cleared Apr 22, 1998
MICROKERATOME OR THE MATE
K974598 · HNO
Howard Instruments, Inc.
Ophthalmic · 134d
Cleared Apr 22, 1998
FREQUENCY UV (ETAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND...
K980634 · LPL
Aspect Vision Care, Ltd.
Ophthalmic · 62d
Cleared Apr 22, 1998
UROLOGICAL BALLOON DILATATION CATHETER
K980795 · EZN
Boston Scientific Corp
Gastroenterology & Urology · 51d
Cleared Apr 22, 1998
GALAXY INTRAVASCULAR ULTRASOUND SYSTEM, MODEL I5028
K980851 · IYO
Boston Scientific Corp
Radiology · 48d
Cleared Apr 22, 1998
MAICO MA53
K981142 · EWO
Bernafon-Maico, Inc.
Ear, Nose, Throat · 23d
Cleared Apr 22, 1998
MANAN MANTA CATHETER FIXATION DISK
K981229 · KNY
Medical Device Technologies, Inc.
Gastroenterology & Urology · 19d
Cleared Apr 22, 1998
MANAN MALECOT BASKET DRAINAGE CATHETER
K981258 · FEW
Medical Device Technologies, Inc.
Gastroenterology & Urology · 16d
Cleared Apr 22, 1998
DUAL LUER LOCK CAP
K981318 · FPA
Baxter Healthcare Corp
General Hospital · 12d