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
124585–124608 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 12, 1990
HAND-CARRIED STRETCHERS/BREAK AWAY FLAT
K904511 · FPP
Minto Research & Development, Inc.
General Hospital · 10d
Cleared Oct 12, 1990
PATIENT EXAMINATION GLOVES
K904525 · LYY
Jian Win Latex Product Factory
General Hospital · 15d
Cleared Oct 11, 1990
SUNGLASSES
K902224 · HQY
Jasco Products Co., Inc.
Ophthalmic · 147d
Cleared Oct 11, 1990
IONTOPHORESIS DEVICE
K903093 · EGJ
Empi
Physical Medicine · 90d
Cleared Oct 11, 1990
MARQUEST SCT 3000, HEATED HUMIDIFICATION SYSTEM
K903138 · BTT
Marquest Medical Products, Inc.
Anesthesiology · 86d
Cleared Oct 11, 1990
AUTO SUTURE(R) ENDOSCOPIC CLAMP
K903205 · HDA
United States Surgical, A Division of...
Obstetrics & Gynecology · 83d
Cleared Oct 11, 1990
SHARPLAN CO2 LASERS, MODEL NUMBERS 1050 AND 1075
K903230 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 80d
Cleared Oct 11, 1990
SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES
K903303 · HPS
Spembly Medical , Ltd.
Ophthalmic · 79d
Cleared Oct 11, 1990
MDLS 4000/4900/6000/8000/8900/LUXUS 60/100 ND:YAG
K903444 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 76d
Cleared Oct 11, 1990
POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES
K903584 · GAW
Look, Inc.
General & Plastic Surgery · 64d