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
90001–90024 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 13, 1998
LOVYTEX SDN BHD POWDER-FREE LATEX EXAMINATION GLOVES
K980618 · LYY
Lovytex Sdn Bhd
General Hospital · 23d
Cleared Mar 12, 1998
BICOAG COAGULATING FORCEPS
K971565 · HIN
Everest Medical Corp.
Obstetrics & Gynecology · 317d
Cleared Mar 12, 1998
CARDIOSMART ST
K973403 · LOS
Marquette Medical Systems, Inc.
Cardiovascular · 184d
Cleared Mar 12, 1998
TS2000 MEDICAL DEVICE MONITOR
K973640 · MSX
Trincore Systems, Inc.
Cardiovascular · 169d
Cleared Mar 12, 1998
BREATHING CIRCUIT BACTERIAL FILTER
K973797 · CAH
King Systems Corp.
General Hospital · 157d
Cleared Mar 12, 1998
BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS
K974756 · HWC
Biodynamic Technologies, Inc.
Orthopedic · 83d
Cleared Mar 12, 1998
LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER
K974796 · FFK
Medispec, Ltd.
Gastroenterology & Urology · 80d
Cleared Mar 11, 1998
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)
K970653 · MSF
Baxter Healthcare Corp
Gastroenterology & Urology · 383d
Cleared Mar 11, 1998
CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210)
K970662 · MSF
Baxter Healthcare Corp
Gastroenterology & Urology · 383d
Cleared Mar 11, 1998
ELECTROCARDIOGRAPHS MODELS 110B, 120B AND 310B
K972603 · DPS
Dr. Lee Co., Ltd.
Cardiovascular · 243d
Cleared Mar 11, 1998
TEMPORARY OCCLUSION BALLOON SYSTEM
K972777 · MJN
Percu Surge, Inc.
Cardiovascular · 229d
Cleared Mar 11, 1998
CREST TOOTHBRUSH WITH MICROSHIELD
K973236 · EFW
Procter & Gamble Co.
Dental · 195d
Cleared Mar 11, 1998
ZEFON ADULT ANESTHESIA BREATHING CIRCUIT WITH FILTER, ZEFON PEDIATRIC...
K973238 · CAH
Bill Olson Corp.
General Hospital · 195d
Cleared Mar 11, 1998
23:1 REDUCTION ANGLE
K973800 · EGS
Midwest Dental Products Corp.
Dental · 156d
Cleared Mar 11, 1998
CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30
K973999 · CGS
Diagnostic Chemicals , Ltd.
Chemistry · 141d
Cleared Mar 11, 1998
BRUXTRAK MATERIAL
K974160 · EBI
Bruxcare, LLC
Dental · 126d
Cleared Mar 11, 1998
MULTITEST CD3/CD8/CD45/CD4
K974360 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 112d
Cleared Mar 11, 1998
FRIALIT-2 PROTECT ABUTMENT
K974628 · DZE
Friatec AG
Dental · 90d
Cleared Mar 11, 1998
72 HOUR USE TRACH CARE WITH MICROBAN
K974630 · CAH
Ballard Medical Products
General Hospital · 89d
Cleared Mar 11, 1998
ATHENA 20R S TYPE SLOW SPEED HANDPIECE MOTOR
K974671 · EFB
Athena Technology, Inc.
Dental · 86d
Cleared Mar 11, 1998
REUSABLE FINGER SENSOR 3444
K974697 · DQH
Bci Intl., Inc.
Cardiovascular · 85d
Cleared Mar 11, 1998
SOFLENS(TM) ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT LENS
K974780 · LPL
Bausch & Lomb, Inc.
Ophthalmic · 79d
Cleared Mar 11, 1998
CO-STAT(TM) END TIDAL BREATH ANALYZER
K974805 · GHS
Natus Medical, Inc.
Hematology · 78d
Cleared Mar 11, 1998
6 INCH MINI-BONE EXTENSION SET WITH LUER LOCK, NES01S, 6 INCH MIN-BONE...
K980127 · FPA
Catheter Innovations, Inc.
General Hospital · 56d