FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
80449–80472 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 13, 2000
NEXTSTITCH CARDIOVASCULAR VALVE SUTURE
K001440 · GAT
Genzyme Surgical Product (Genzyme...
General & Plastic Surgery · 189d
Cleared Nov 13, 2000
SOF-TACT DIABETES MANAGEMENT SYSTEM
K001993 · LFR
Abbott Laboratories
Chemistry · 137d
Cleared Nov 13, 2000
MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714
K002023 · LYR
Medmira Laboratories, Inc.
Microbiology · 133d
Cleared Nov 13, 2000
AMT SPINAL SYSTEM
K002059 · KWP
Micron Precision Engineering, Inc.
Orthopedic · 130d
Cleared Nov 13, 2000
ROVERS SPATULA
K002520 · HHT
Rovers Medical Devices B.V.
Obstetrics & Gynecology · 90d
Cleared Nov 13, 2000
SPARTAN MTS
K002521 · ELC
Spartan Marketing Group
Dental · 90d
Cleared Nov 13, 2000
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
K002552 · KRO
Howmedica Osteonics Corp.
Orthopedic · 88d
Cleared Nov 13, 2000
SURGICAL SYSTEM WITH CRYOGUIDE
K002615 · GEH
Endocare, Inc.
General & Plastic Surgery · 83d
Cleared Nov 13, 2000
NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM
K002677 · BXM
Nuvasive, Inc.
Anesthesiology · 77d
Cleared Nov 13, 2000
TISSUELINK MONOPOLAR FLOATING BALL'
K002680 · GEI
Tissuelink Medical, Inc.
General & Plastic Surgery · 77d
Cleared Nov 13, 2000
ALLON 2001 MODIFIED
K003349 · DWJ
Mtre Advanced Technology , Ltd.
Cardiovascular · 18d
Cleared Nov 09, 2000
SAMSUNG 10DR IMPLANT SYSTEM
K002062 · EHD
Samsung Sds Co., Ltd.
Radiology · 126d
Cleared Nov 09, 2000
100 S AND 100 LC AND 485 ANSER ULTRASOUND IMAGING SYSTEMS
K002357 · IYO
Pie Medical
Radiology · 99d
Cleared Nov 09, 2000
REPLACE TPS COATED IMPLANTS
K002475 · DZE
Nobel Biocare Uas, Inc.
Dental · 90d
Cleared Nov 09, 2000
LUMBOPERITONEAL SHUNT SYSTEM
K002476 · JXG
Phoenix Biomedical Corp.
Neurology · 90d
Cleared Nov 09, 2000
PRECIMED TRAUMA SYSTEM
K002486 · HRS
Patrick Berdoz
Orthopedic · 87d
Cleared Nov 09, 2000
FETALGARD LITE
K002503 · HGM
Analogic Corp.
Obstetrics & Gynecology · 87d
Cleared Nov 09, 2000
ZYNERGY Z4 TRANSVENOUS BIPOLAR PACING CATHETER, MODEL 04-X-02-3-10-3
K002687 · LDF
Zynergy Cardiovascular, Inc.
Cardiovascular · 72d
Cleared Nov 09, 2000
CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS)
K002693 · EBL
Cbs Intl. B.V.
Dental · 72d
Cleared Nov 09, 2000
FORMULA ONE STERILE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING...
K002720 · LYY
Tillotson Healthcare Corp.
General Hospital · 70d
Cleared Nov 09, 2000
KENDRO HERACELL CO2 INCUBATOR
K002805 · MQG
Kendro Laboratory Products, L.P.
Obstetrics & Gynecology · 62d
Cleared Nov 09, 2000
SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM
K003179 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 29d
Cleared Nov 08, 2000
ETEST LINEZOLID
K002139 · LTX
Ab Biodisk
Microbiology · 114d
Cleared Nov 08, 2000
PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH
K002459 · DPS
Agilent Technologies, Inc.
Cardiovascular · 90d