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
90505–90528 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 13, 1998
LATEX EXAMINATION GLOVES
K980215 · LYY
P.T. Wantong Industry
General Hospital · 51d
Cleared Mar 13, 1998
ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA
K980249 · LFG
Princeton BioMeditech Corp.
Toxicology · 49d
Cleared Mar 13, 1998
POWDERFREE BLUE NITRILE EXAMINATION GLOVES (POLYMER COATED)
K980275 · LZA
Besglove Medicare Sdn. Bhd.
General Hospital · 46d
Cleared Mar 13, 1998
POWDERED NITRILE EXAMINATION GLOVES (BLUE COLOUR)
K980280 · LZA
Besglove Medicare Sdn. Bhd.
General Hospital · 46d
Cleared Mar 13, 1998
POWDERFREE BLUE NITRILE EXAMINATION GLOVES
K980285 · LZA
Besglove Medicare Sdn. Bhd.
General Hospital · 46d
Cleared Mar 13, 1998
OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE
K980419 · LZA
Omnigrace (Thailand) , Ltd.
General Hospital · 38d
Cleared Mar 13, 1998
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED
K980421 · LZA
Omnigrace (Thailand) , Ltd.
General Hospital · 38d
Cleared Mar 13, 1998
NITRILE EXAMINATION GLOVES - POWDER FREE
K980511 · LZA
Influx Pacific Sdn. Bhd.
General Hospital · 31d
Cleared Mar 13, 1998
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (GREEN)
K980572 · LYY
Hartalega Sdn Bhd
General Hospital · 24d
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