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

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175,820 results
133657–133680 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 05, 1988
CHRONODYNAMICS DATA RECORDER (CDR)-100
K881813 · FLL
Chronodynamics, Inc.
General Hospital · 221d
Cleared Dec 05, 1988
BLOOD RESERVOIR, CARDIOPULMONARY BYPASS
K882414 · DTN
Gish Biomedical, Inc.
Cardiovascular · 175d
Cleared Dec 05, 1988
INDIRECT FLUORESCENT ASSAY FOR (HCMV)
K882835 · GQH
Stellar Bio Systems, Inc.
Microbiology · 150d
Cleared Dec 05, 1988
KIM NASO-INTESTINAL TUBE
K882918 · KNT
Sheridan Catheter Corp.
Gastroenterology & Urology · 146d
Cleared Dec 05, 1988
ENCOR UNIPOLAR VS-1 LEADS
K883070 · DTB
Cordis Leads, Inc.
Cardiovascular · 138d
Cleared Dec 05, 1988
SARNS MP4 CARDIOPLEGIA DELIVERY SYSTEM
K883071 · DTR
3M Health Care, Sarns
Cardiovascular · 138d
Cleared Dec 05, 1988
IMMUKNOW-CHECK HCG ASSAY KIT, CAT. #900-40
K883148 · DHA
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 132d
Cleared Dec 05, 1988
HILL NASOGASTRIC TUBE
K883319 · KNT
Zinetics Medical, Inc.
Gastroenterology & Urology · 122d
Cleared Dec 05, 1988
FLEXIBLE MYOCARDIAL BIOPSY FORCEPS
K883723 · DWZ
Cook, Inc.
Cardiovascular · 96d
Cleared Dec 05, 1988
IONODENT II (6 VOLTS)
K883761 · EFW
U.S. Apatite Corp.
Dental · 90d
Cleared Dec 05, 1988
PROSTATIC CORE-CUT NEEDLE
K883884 · KNW
Euro-Med Intl.
Gastroenterology & Urology · 83d
Cleared Dec 05, 1988
ISO-100 ISOLATION AMPLIFIER
K883947 · GYE
Telediagnostic Systems, Inc.
Neurology · 77d
Cleared Dec 05, 1988
LANDMARK VENOUS ACCESS DRIVE (ADDITIONAL SIZES)
K883980 · FOZ
Menlo Care, Inc.
General Hospital · 75d
Cleared Dec 05, 1988
SYSMEX NE-8000
K883997 · GKZ
Toa Medical Electronics USA, Inc.
Hematology · 76d
Cleared Dec 05, 1988
RUBEOLA TEST
K884004 · GRE
Gull Laboratories, Inc.
Microbiology · 75d
Cleared Dec 05, 1988
ENDOCARDIAL PACING LEADS-ANCHORING SLEEVE MODIFIED
K884005 · DTB
Medtronic Vascular
Cardiovascular · 75d
Cleared Dec 05, 1988
HEMAT 12
K884006 · GKZ
Texas Intl. Laboratories, Inc.
Hematology · 75d
Cleared Dec 05, 1988
USCI TANDEM ADAPTER
K884200 · DTL
C.R. Bard, Inc.
Cardiovascular · 60d
Cleared Dec 05, 1988
INTERSEPT* PREBYPASS FILTER
K884244 · KRJ
Medtronic Blood Systems, Inc.
Cardiovascular · 55d
Cleared Dec 05, 1988
FILTRAL TM 8 HEMODIALYZER
K884326 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 52d
Cleared Dec 05, 1988
GASTROSTOMY FEEDING DEVICE
K884439 · KNT
Southside Biotechnology
Gastroenterology & Urology · 45d
Cleared Dec 05, 1988
MAXITHINS REGULAR PADS, DEODORANT
K884444 · HHL
Tambrands, Inc.
Obstetrics & Gynecology · 45d
Cleared Dec 05, 1988
MAXITHINS PANTY SHIELDS, DEODORANT
K884445 · HHL
Tambrands, Inc.
Obstetrics & Gynecology · 45d
Cleared Dec 05, 1988
CHELON-FIL
K884475 · EMA
Espe GmbH (Us)
Dental · 41d