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
122329–122352 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 25, 1991
PATIENT EXAMINATION LATEX GLOVES (NON-STERILE)
K911694 · LYY
Guthrie Medicare Products (Melaka)...
General Hospital · 9d
Cleared Apr 24, 1991
MAUNA LOA ENHANCED HEATED BREATHING CIRCUIT
K904538 · CAI
Mauna Loa Medical, Inc.
Anesthesiology · 202d
Cleared Apr 24, 1991
SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM)
K910204 · DQO
Baxter Healthcare Corp
Cardiovascular · 98d
Cleared Apr 24, 1991
ACID CONCENTRATE SOLUTIONS
K910319 · KPO
Biopharm, Inc.
Gastroenterology & Urology · 90d
Cleared Apr 24, 1991
FUJI COMPUTED RADIOGRAPHY SYSTEM FCR 7501
K910437 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 83d
Cleared Apr 24, 1991
ROCHE REAGENT FOR TOTAL BILIRUBIN
K910591 · CIG
Roche Diagnostic Systems, Inc.
Chemistry · 71d
Cleared Apr 24, 1991
ROCHE REAGENT FOR DIRECT BILIRUBIN
K910593 · CIG
Roche Diagnostic Systems, Inc.
Chemistry · 71d
Cleared Apr 24, 1991
BAG SPIGOT
K910673 · KPE
Procedure Products, Inc.
General Hospital · 68d
Cleared Apr 24, 1991
GRADUATED CYLINDER OF EXTERNAL DRAINAGE SET
K910853 · JXG
Cordis Corp.
Neurology · 55d
Cleared Apr 24, 1991
NOVOSTE GUIDING CATHETER
K911527 · DQY
Novoste Corp.
Cardiovascular · 20d
Cleared Apr 24, 1991
PHARMACIA SPECIFIC IGE CONTROL
K911631 · DGC
Pharmacia, Inc.
Immunology · 13d
Cleared Apr 23, 1991
ANESTHESIA CONDUCTION FILTER
K902666 · BSN
Arbor Technologies, Inc.
Anesthesiology · 309d
Cleared Apr 23, 1991
CCI CORNEAL SCARIFIER
K904505 · GDX
Buckman Co., Inc.
General & Plastic Surgery · 203d
Cleared Apr 23, 1991
D2 SPECTRUM GAMMA CAMERA/CRYSTAL V COMPUTER SYSTEM
K904599 · JWM
Digital Design, Inc.
Radiology · 195d
Cleared Apr 23, 1991
SLEEPAP
K905593 · BZD
Medical Industries America, Inc.
Anesthesiology · 131d
Cleared Apr 23, 1991
GE QUADRATURE CERVICAL SPINE SURF COIL, M1285AR
K910817 · LNH
General Electric Co.
Radiology · 56d
Cleared Apr 23, 1991
KODAK EKTASCAN DIGITAL INTERFACE/FOR AT&T
K911405 · LMD
Eastman Kodak Company
Radiology · 25d
Cleared Apr 23, 1991
LAPAROSCOPIC SUCTION IRRIGATION TUBING SET
K911484 · GCJ
United States Endoscopy Group, Inc.
General & Plastic Surgery · 19d
Cleared Apr 23, 1991
GRANSTAND
K911608 · IPL
Prime Engineering
Physical Medicine · 13d
Cleared Apr 22, 1991
INTERMEDICS MODEL 431-11 IMPLANT ENDOCARD PAC LEAD
K903948 · DTB
Intermedics, Inc.
Cardiovascular · 238d
Cleared Apr 22, 1991
MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST
K904832 · DXK
Hewlett-Packard Co.
Cardiovascular · 181d
Cleared Apr 22, 1991
STYLET TRACHAEL TUBE
K905133 · BSR
Medical Devices, Inc.
Anesthesiology · 158d
Cleared Apr 22, 1991
MD CO2 SURGICAL LASER SYSTEM/GEN. SURGERY AND ORTH
K905676 · GEX
Laser Engineering, Inc.
General & Plastic Surgery · 125d
Cleared Apr 22, 1991
X-T AIR DRILL
K905800 · ERL
Xomed-Treace, Inc.
Ear, Nose, Throat · 115d