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
37057–37080 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 17, 2014
HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP,...
K141647 · DIO
Healgen Scientific, LLC
Chemistry · 28d
Cleared Jul 16, 2014
G-TL
K133568 · MQL
Vitrolife, Inc.
Obstetrics & Gynecology · 238d
Cleared Jul 16, 2014
CHOICE SPINE LUMBAR SPACER SYSTEM (SABRE, SHARK, HORNET, HARPOON)
K140142 · MAX
Choicespine, LP
Orthopedic · 175d
Cleared Jul 16, 2014
PROCTIGARD
K140558 · PHN
Access Pharmaceuticals, Inc.
Gastroenterology & Urology · 133d
Cleared Jul 16, 2014
PORCINE ANORGANIC BONE MINERAL
K140714 · NPM
Collagen Matrix, Inc.
Dental · 117d
Cleared Jul 16, 2014
BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC
K140844 · MQV
Synergy Biomedical, Inc.
Orthopedic · 105d
Cleared Jul 16, 2014
SENSITITRE SUSCEPTIBILITY PLATES
K141000 · JWY
Thermo Fisher Scientific
Microbiology · 89d
Cleared Jul 16, 2014
STERLING OVER-THE WIRE PTA BALLOON DILATATION CATHETER
K141112 · LIT
Boston Scientific
Cardiovascular · 77d
Cleared Jul 16, 2014
ACCULIF TL AND PL CAGE
K141217 · MAX
Stryker Corporation
Orthopedic · 65d
Cleared Jul 16, 2014
SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC
K141563 · MQB
Rayence Co., Ltd.
Radiology · 34d
Cleared Jul 16, 2014
SOLID STATE X-RAY IMAGING DEVICE, DIGIITAL FLAT PANEL X-RAY DETECTOR, 1417WCC
K141566 · MQB
Rayence Co., Ltd.
Radiology · 34d
Cleared Jul 15, 2014
HEARTWAY POWER WHEELCHAIR
K132856 · ITI
Heartway Medical Products Co., Ltd.
Physical Medicine · 306d
Cleared Jul 15, 2014
MILESTONE SPINAL SYSTEM
K133053 · MAX
Weigao Orthopaedic Device Co., Ltd.
Orthopedic · 291d
Cleared Jul 15, 2014
FLXFIT INTERVERTEBRAL BODY FUSION DEVICE
K133813 · MAX
Expanding Orthopedics, Inc.
Orthopedic · 211d
Cleared Jul 15, 2014
AESCULAP OPTILENE NONABSORBABLE SUTURE
K133890 · GAW
Aesculap, Inc.
General & Plastic Surgery · 207d
Cleared Jul 15, 2014
VICTUS FEMTOSECOND LASER PLATFORM
K140615 · OOE
Technolas Perfect Vision GmbH
Ophthalmic · 127d
Cleared Jul 15, 2014
ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM
K140753 · OCX
Medivators
Gastroenterology & Urology · 111d
Cleared Jul 15, 2014
CORMATRIX ECM FOR VASCULAR REPAIR
K140789 · DXZ
Cormatrix Cardiovascular, Inc.
Cardiovascular · 106d
Cleared Jul 15, 2014
REPROCESSED KENDALL SCD EXPRESS COMPRESSION SLEEVES
K140813 · JOW
Covidien
Cardiovascular · 105d
Cleared Jul 15, 2014
GMK SPHERE EXTENSION
K140826 · JWH
Medacta International
Orthopedic · 105d
Cleared Jul 15, 2014
LINSCAN 808, LINSCAN 980
K141063 · GEX
Gme (German Medical Engineering) GmbH
General & Plastic Surgery · 82d
Cleared Jul 15, 2014
PULSTAR LOGIX PUMP
K141609 · JOW
Albahealth, LLC
Cardiovascular · 29d
Cleared Jul 14, 2014
PFX SPINOUS PROCESS FIXATION SYSTEM
K132765 · PEK
Innovasis, Inc.
Orthopedic · 313d
Cleared Jul 14, 2014
CONSENSUS VITALITE TIBIAL INSERT
K133919 · JWH
Consensus Orthopedics, Inc.
Orthopedic · 203d