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.

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

Filters: Cleared only ×
175,230 results
35593–35616 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 30, 2014
ACROSSPINE PEDICLE SCREW SYSTEM
K141695 · NKB
Arthro-Dif
Orthopedic · 189d
Cleared Dec 30, 2014
TRIA FANP
K141868 · ONG
Tria Beauty, Inc.
General & Plastic Surgery · 173d
Cleared Dec 30, 2014
NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE
K142173 · LHC
Ecolab, Inc.
General Hospital · 145d
Cleared Dec 30, 2014
3.Omm Biomet Cannulated Screw System
K143188 · HWC
Biomet Manufacturing Corp
Orthopedic · 55d
Cleared Dec 29, 2014
VECTRIX EXTERNAL FIXATOR
K140649 · NDK
3D Medical Concepts, LLC
Orthopedic · 291d
Cleared Dec 29, 2014
MICROBLAB, MICROLOOP
K141936 · BZG
Carefusion Germany 234 GmbH
Anesthesiology · 165d
Cleared Dec 29, 2014
G7 Finned Acetabular Shell
K142746 · LPH
Biomet Manufactuting Corp.
Orthopedic · 96d
Cleared Dec 29, 2014
AQUARIUS Gastrostomy Replacement Tube
K143378 · KNT
Degania Silicone , Ltd.
Gastroenterology & Urology · 34d
Cleared Dec 24, 2014
MIDI-SRS
K141046 · ONG
Srmc Co., Ltd.
General & Plastic Surgery · 245d
Cleared Dec 24, 2014
HONGYUN POWDER-FREE YELLOW VINYL PATIENT EXAMINATION GLOVES
K141878 · LYZ
Tangshan Hongyun Plastic Products...
General Hospital · 166d
Cleared Dec 24, 2014
Straight Stud Attachment
K142407 · NHA
Sterngold Dental, LLC
Dental · 118d
Cleared Dec 24, 2014
CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT...
K142429 · HCG
Codman & Shurtleff, Inc.
Neurology · 117d
Cleared Dec 24, 2014
IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000...
K143352 · JJX
Siemens Healthcare Diagnostics, Inc.
Immunology · 30d
Cleared Dec 23, 2014
Burn Resuscitation Decision Support System - Clinical (BRDSS-C)
K140387 · PDT
The Surgeon General, Department of...
General & Plastic Surgery · 312d
Cleared Dec 23, 2014
ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT...
K140436 · OSX
Fujirebio Diagnostics,Inc.
Chemistry · 305d
Cleared Dec 23, 2014
KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS
K141479 · LZH
Covidien
General Hospital · 202d
Cleared Dec 23, 2014
Wrist Hemiarthroplasty System
K141920 · KWN
Arthrosurface, Inc.
Orthopedic · 160d
Cleared Dec 23, 2014
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
K142151 · JWY
Thermo Fisher Scientific
Microbiology · 139d
Cleared Dec 23, 2014
HP Tissue Matrix
K142326 · FTM
Lifecell Corporation
General & Plastic Surgery · 125d
Cleared Dec 23, 2014
nvc
K142328 · ODP
Nvision Biomedical Technologies, LLC
Orthopedic · 125d
Cleared Dec 23, 2014
TISSUE CONTAINMENT SYSTEM
K142427 · GCJ
Applied Medical Resources
General & Plastic Surgery · 116d
Cleared Dec 23, 2014
ALIANS ULNA LOCKING PLATING SYSTEM
K142502 · HRS
Newclip Technics
Orthopedic · 109d
Cleared Dec 23, 2014
JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis...
K142564 · FIE
JMS North America Corporation
Gastroenterology & Urology · 103d
Cleared Dec 23, 2014
Instru-Safe Instrument Protection System
K142630 · KCT
Summit Medical, Inc.
General Hospital · 97d