FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
74185–74208 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 09, 2002
SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS...
K022489 · CAC
Summit Medical , Ltd.
Anesthesiology · 72d
Cleared Oct 09, 2002
BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM
K022580 · CGA
Becton, Dickinson & CO
Chemistry · 65d
Cleared Oct 09, 2002
BECTON DICKINSON LOGIC BLOOD GLUCOSE MONITORING SYSTEM
K022581 · NBW
Becton, Dickinson & CO
Chemistry · 65d
Cleared Oct 09, 2002
MODIFICATION TO FOCUS
K022630 · EHD
Instrumentarium Corp.
Radiology · 63d
Cleared Oct 09, 2002
POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS...
K022665 · KKY
Hohenstein Enterprises, Inc.
General & Plastic Surgery · 61d
Cleared Oct 09, 2002
PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P.
K022666 · NEW
Arc Medical Supplies (Beijing) Co, Ltd.
General & Plastic Surgery · 61d
Cleared Oct 09, 2002
REPROCESSED DISPOSABLE TROCARS
K022743 · KAB
Medical Device Services
Ear, Nose, Throat · 51d
Cleared Oct 09, 2002
REPROCSSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS
K022748 · HET
Medical Device Services
Obstetrics & Gynecology · 51d
Cleared Oct 09, 2002
EPOCH XP NEUROLOGICAL WORKSTATION
K022785 · GWQ
Axon Systems, Inc.
Neurology · 48d
Cleared Oct 09, 2002
W-5
K022811 · EJT
Ivoclar Vivadent, Inc.
Dental · 47d
Cleared Oct 09, 2002
CLEAR-IT ANTI-FOG, MODEL PS003
K022826 · OCT
Preservation Solutions, Inc.
Gastroenterology & Urology · 44d
Cleared Oct 09, 2002
VITA IN-CERAM YZ CUBES FOR CEREC
K022996 · EIH
Vident
Dental · 30d
Cleared Oct 09, 2002
ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM
K023102 · MEH
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Oct 09, 2002
JET-X TIN COATED HALF PINS
K023134 · JDW
Smith & Nephew, Inc.
Orthopedic · 19d
Cleared Oct 09, 2002
NITRILE POWDER-FREE EXAMINATION GLOVES
K023170 · LZA
Allegiance Healthcare Corp.
General Hospital · 16d
Cleared Oct 09, 2002
OPART (INCLUDING OPART ULTRA AND ULTRA GRADIENT UPGRADE KIT)
K023207 · LNH
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Oct 09, 2002
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA
K023285 · NHX
Axis-Shield Diagnostics, Ltd.
Immunology · 23d
Cleared Oct 09, 2002
BOSWORTH CORACO-CLAVICULAR SCREW
K023294 · HWC
Howmedica Osteonics Corp.
Orthopedic · 7d
Cleared Oct 09, 2002
OCO DENTAL IMPLANT (5.0MM DIAMETER)
K023336 · DZE
"O" Co., Inc.
Dental · 2d
Cleared Oct 08, 2002
FOCUS RADIATION TREATMENT PLANNING SYSTEM
K020027 · MUJ
Computerized Medical Systems, Inc.
Radiology · 277d
Cleared Oct 08, 2002
OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4
K020507 · GWG
Olympus Winter & Ibe GmbH
Neurology · 235d
Cleared Oct 08, 2002
MODEL 4310 PSARRAY2 EEG ELECTRODE
K020670 · GXY
Physiometrix, Inc.
Neurology · 221d
Cleared Oct 08, 2002
ARTEMIS
K021333 · IYO
Ultralink, LLC
Radiology · 165d
Cleared Oct 08, 2002
SIMPLIFY COMPACT RESUSCITATOR
K021716 · BTM
Polymed (Xiamen) Plastic Industrial...
Anesthesiology · 138d