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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
68857–68880 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 02, 2004
SYNERGY SPINE ARRAY COIL
K033662 · MOS
Philips Medical Systems, Inc.
Radiology · 73d
Cleared Feb 02, 2004
GRADIA GUM
K033808 · EBF
GC America, Inc.
Dental · 56d
Cleared Feb 02, 2004
ORTHOPACS
K033825 · LLZ
Etrauma.Com Corp.
Radiology · 54d
Cleared Feb 02, 2004
CT COMPATIBLE INTRAUTERINE SLEEVES, CAT #0311, 9406
K033828 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 54d
Cleared Feb 02, 2004
MINXRAY, MODEL HF120/60H POWERPLUS
K040046 · IZL
Minxray, Inc.
Radiology · 21d
Cleared Feb 02, 2004
MOBILE COMPACT DIGITAL CARDIAC CAMERA
K040057 · KPS
Is2 Research, Inc.
Radiology · 20d
Cleared Jan 30, 2004
JOSTRA SUCKERS, MODEL JS
K020983 · DWF
Jostra AG
Cardiovascular · 674d
Cleared Jan 30, 2004
WATERLASE
K030523 · GEX
Biolase Technology, Inc.
General & Plastic Surgery · 345d
Cleared Jan 30, 2004
VADI MANUAL RESUSCITATOR
K030864 · BTM
Vedi Corp.
Anesthesiology · 318d
Cleared Jan 30, 2004
ESA PLASMA FREE METANEPHRINE ANALYSIS KIT
K032199 · CHQ
Esa, Inc.
Chemistry · 196d
Cleared Jan 30, 2004
STREET
K032765 · ITI
Permobil AB
Physical Medicine · 147d
Cleared Jan 30, 2004
GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS
K033055 · CGA
Diamond Diagnostics, Inc.
Chemistry · 123d
Cleared Jan 30, 2004
BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT
K033056 · CDS
Diamond Diagnostics, Inc.
Chemistry · 123d
Cleared Jan 30, 2004
CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS
K033058 · CGX
Diamond Diagnostics, Inc.
Chemistry · 123d
Cleared Jan 30, 2004
PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD
K033182 · HNO
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 121d
Cleared Jan 30, 2004
ERBE HELIX HYDRO-JET
K033590 · FQH
Erbe USA, Inc.
General Hospital · 81d
Cleared Jan 30, 2004
ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME...
K033606 · NBC
Axis-Shield Diagnostics, Ltd.
Chemistry · 74d
Cleared Jan 30, 2004
OLYMPUS VIDEO URETEROSCOPE, NTSC
K033651 · FGB
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 71d
Cleared Jan 30, 2004
MTS MULTIPROGRAM TRIAL STIMULATOR SYSTEM
K033757 · GZB
Advanced Neuromodulation Systems
Neurology · 60d
Cleared Jan 30, 2004
KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS
K033796 · KHJ
Heinz Kurz GmbH Medizintechnik
Ear, Nose, Throat · 56d
Cleared Jan 30, 2004
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER
K033811 · DEH
The Binding Site, Ltd.
Immunology · 52d
Cleared Jan 30, 2004
OLYMPUS URINE CALIBRATOR
K033910 · JIX
Cliniqa Corporation
Chemistry · 44d
Cleared Jan 30, 2004
FLOSENSE II, MODEL 29-8040
K033939 · BZG
Sdi Diagnostics, Inc.
Anesthesiology · 46d
Cleared Jan 30, 2004
UCLA AND CEMENT-ON ABUTMENTS AND ACCESSORIES
K034022 · DZE
Diamodent
Dental · 32d