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
70681–70704 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 20, 2003
DUET SYSTEM
K030192 · JOY
Bioview , Ltd.
Hematology · 211d
Cleared Aug 20, 2003
CRYOTRON 2 CRYOTHERAPY DEVICE
K030281 · MLY
Cryonic Medical North America
Physical Medicine · 205d
Cleared Aug 20, 2003
QUANTIX/OR DEVICE
K030357 · DPW
Cardiosonix, Ltd.
Cardiovascular · 198d
Cleared Aug 20, 2003
ISM1+, IMS2+, AND UTM+
K030490 · MQL
Medicult A/S
Obstetrics & Gynecology · 187d
Cleared Aug 20, 2003
PERFECT CAPSULE
K030957 · HQC
Milvella Pty. , Ltd.
Ophthalmic · 146d
Cleared Aug 20, 2003
S & C -BRACKET ADHESIVES
K031420 · DYH
S & C Polymer GmbH
Dental · 107d
Cleared Aug 20, 2003
NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D)
K031551 · KTB
Vyteris, Inc.
Physical Medicine · 93d
Cleared Aug 20, 2003
ELECYS SHBG CALCHECK
K031698 · JJX
Roche Diagnostics Corp.
Chemistry · 79d
Cleared Aug 20, 2003
SAPPHIRE DETACHABLE FIBER COILS
K031852 · HCG
Micro Therapeutics, Inc.
Neurology · 65d
Cleared Aug 20, 2003
ELECSYS PRECICONTROL TROPONIN T
K031990 · JJX
Roche Diagnostics Corp.
Toxicology · 54d
Cleared Aug 20, 2003
TISSUELINK FLOATING BALL MODEL 23-201-1
K032132 · GEI
Tissuelink Medical, Inc.
General & Plastic Surgery · 40d
Cleared Aug 20, 2003
OMNILIGHT FLUORESCENT PULSED LIGHT SYSTEM
K032191 · GEX
Luxsano AB
General & Plastic Surgery · 34d
Cleared Aug 20, 2003
AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP
K032198 · HCH
Aesculap, Inc.
Neurology · 33d
Cleared Aug 20, 2003
MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
K032204 · GEX
Vascular Solutions, Inc.
General & Plastic Surgery · 33d
Cleared Aug 20, 2003
COBRA COOLED SURGICAL PROBE, MODEL M004159670
K032207 · GEI
Boston Scientific Corp
General & Plastic Surgery · 33d
Cleared Aug 20, 2003
EP-WORKMATE WITH RPM SYSTEM
K032225 · DQK
Ep Medsystems
Cardiovascular · 30d
Cleared Aug 20, 2003
DESIGNS FOR VISION FIBEROPTIC LIGHT
K032283 · GDB
Designs For Vision, Inc.
Gastroenterology & Urology · 27d
Cleared Aug 19, 2003
NX SYSTEM
K030222 · DRG
American Telecare, Inc.
Cardiovascular · 209d
Cleared Aug 19, 2003
ADVISOR, MODEL 9200
K030407 · CCK
Bci, Inc.
Anesthesiology · 193d
Cleared Aug 19, 2003
MIRAGE VISTA MASK
K031047 · BZD
Resmed, Ltd.
Anesthesiology · 139d
Cleared Aug 19, 2003
ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS03-1
K031427 · IPF
Biomedical Life Systems, Inc.
Physical Medicine · 105d
Cleared Aug 19, 2003
SIEMENS INFINITY MODULAR MONITORS, MODELS SC 7000, SC 9000XL AND SC 8000 WITH...
K031433 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 105d
Cleared Aug 19, 2003
PITANGA
K031489 · GEX
Syneron Medical, Ltd.
General & Plastic Surgery · 99d
Cleared Aug 19, 2003
SYNDEO PCA SYRINGE PUMP, MODEL 2L3113
K031566 · MEA
Baxter Healthcare Corp
General Hospital · 92d