Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
70201–70224 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 02, 2004
AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1
K030849 · JJX
N-Dia, Inc.
Chemistry · 322d
Cleared Feb 02, 2004
CHASE CARDIAC ANALYSIS SYSTEM
K032531 · LLZ
Chase Medical, Inc.
Radiology · 171d
Cleared Feb 02, 2004
PORTABLE X-RAY UNIT, MODELS PXP-15/20/40HF
K032628 · IZL
United Radiology Systems, Inc.
Radiology · 160d
Cleared Feb 02, 2004
STV PRO 2
K033419 · EIA
Trophy Radiologie
Dental · 98d
Cleared Feb 02, 2004
COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE
K033506 · KWS
Biomet, Inc.
Orthopedic · 89d
Cleared Feb 02, 2004
BELIMED STEAM STERILIZER TOP 5000, SERIES 4 - 8
K033538 · FLE
Sauter AG
General Hospital · 84d
Cleared Feb 02, 2004
AQUIFY MULTI-PURPOSE SOLUTION
K033608 · LPN
Ciba Vision Corporation
Ophthalmic · 77d
Cleared Feb 02, 2004
SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE
K033656 · LRX
Sauflon Pharmaceuticals, Ltd.
Ophthalmic · 73d
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