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
123985–124008 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 12, 1990
STATLAB A-350 SALIVA ALCOHOL TEST
K903235 · DIC
Enzymatics C/O Burditt,Bowles,Radzius...
Toxicology · 81d
Cleared Oct 12, 1990
CONTINUUM KNEE SYSTEM (CKS)-MODIFICATION
K903286 · HSX
Techmedica, Inc.
Orthopedic · 88d
Cleared Oct 12, 1990
ROCHE COBAS READY GGT REAGENT
K903304 · JPZ
Roche Diagnostic Systems, Inc.
Chemistry · 80d
Cleared Oct 12, 1990
ALLEGRO LITE THYROID STIMULATING HORMONE CHEM. IMM
K903391 · JLW
Nichols Institute
Chemistry · 77d
Cleared Oct 12, 1990
IL T UPTAKE ASSAY SYSTEM
K903396 · KHQ
Instrumentation Laboratory CO
Chemistry · 77d
Cleared Oct 12, 1990
TDX FREE T3 CALCULATION
K903433 · CDP
Abbott Laboratories
Chemistry · 73d
Cleared Oct 12, 1990
IR-192 IMPLANT
K903465 · KXK
Rads S.L., Inc.
Radiology · 72d
Cleared Oct 12, 1990
SYNERMED ALBUMIN REAGENT KIT
K903543 · CIX
Synermed, Inc.
Chemistry · 66d
Cleared Oct 12, 1990
V-LINK
K903608 · CAW
GE Medical Systems
Radiology · 64d
Cleared Oct 12, 1990
MODIFIED ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM
K903620 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 66d
Cleared Oct 12, 1990
A-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EX.
K903691 · LJT
Therex Corp.
General Hospital · 58d
Cleared Oct 12, 1990
SYNERMED LDH REAGENT KIT
K903773 · CFJ
Synermed, Inc.
Chemistry · 53d
Cleared Oct 12, 1990
FRANZ(TM) STEERABLE COMBINATION CATHETER
K903880 · DRF
Ep Technologies, Inc.
Cardiovascular · 51d
Cleared Oct 12, 1990
SERIES 2000 ADJUSTABLE BED
K903904 · FNL
Equi-Tron Mfg., Inc.
General Hospital · 50d
Cleared Oct 12, 1990
ROCHE COBAS READY RENAL PROFILE REAGENT STRIP
K904049 · JGZ
Roche Diagnostic Systems, Inc.
Chemistry · 38d
Cleared Oct 12, 1990
LITTER, NONRIDGID, POLELESS, NYLON STRETCHER
K904261 · FPP
Dow Cover Co., Inc.
General Hospital · 28d
Cleared Oct 12, 1990
OXLIFE
K904271 · CAW
Medical Repair Service, Inc.
Anesthesiology · 25d
Cleared Oct 12, 1990
HI CHEM BILIRUBIN LINEARITY SET (PRODUCT #88237)
K904293 · JJY
Hichem Diagnostics
Chemistry · 23d
Cleared Oct 12, 1990
DUPONT DIMENSION(R) ETHYL ALCOHOL(ALC) METHOD
K904302 · DIC
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 23d
Cleared Oct 12, 1990
DUPONT ALCOHOL CALIBRATOR
K904308 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 23d
Cleared Oct 12, 1990
SECONDARY CALIBRATORS
K904335 · JGS
Bionostics, Inc.
Chemistry · 22d
Cleared Oct 12, 1990
DIAZO COLORIMENTRY DIRECT BILIRUBIN
K904381 · CIG
Amresco, Inc.
Chemistry · 16d
Cleared Oct 12, 1990
LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION
K904458 · CFT
London Diagnostics, Inc.
Chemistry · 11d
Cleared Oct 12, 1990
HAND-CARRIED STRETCHERS
K904494 · FPP
Minto Research & Development, Inc.
General Hospital · 10d