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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
133057–133080 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 07, 1988
MODIFIED SAW BLADES TO THE SAGITAL SAW
K884839 · KIJ
Dyonics, Inc.
Orthopedic · 16d
Cleared Dec 06, 1988
GV3000 PHACOEMULSIFIER/FRAGMENTER
K883097 · HQC
D.O.R.C. Intl. B.V.
Ophthalmic · 137d
Cleared Dec 06, 1988
ABBOTT A-GENT LIPASE REAGENT
K884596 · CHI
Abbott Laboratories
Chemistry · 33d
Cleared Dec 06, 1988
BECKMAN LAMBDA LIGHT CHAIN REAGENT
K884597 · DFH
Beckman Instruments, Inc.
Immunology · 55d
Cleared Dec 06, 1988
CIBA CORNING MAGIC LITE FSH IMMUNOASSAY
K884687 · CGJ
Ciba Corning Diagnostics Corp.
Chemistry · 28d
Cleared Dec 06, 1988
UNIVERSAL GENERATOR IRRIGATOR MODEL UGI-3000
K884836 · GEI
Meditron Devices, Inc.
General & Plastic Surgery · 18d
Cleared Dec 05, 1988
SYSTEM VI MONITOR
K874326 · DPS
Air-Shields, Inc.
Cardiovascular · 411d
Cleared Dec 05, 1988
OMRON ULTRASONIC NEBULIZER NE-U06
K875134 · CAF
Nidek, Inc.
Anesthesiology · 356d
Cleared Dec 05, 1988
POLYCORD II
K880303 · DSH
Technetics, Inc.
Cardiovascular · 315d
Cleared Dec 05, 1988
CHRONAMED CM101
K881206 · CCK
Chronamed Corp.
Anesthesiology · 259d
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