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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
71185–71208 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 21, 2003
BIOMARC TISSUE MARKER
K032347 · GDW
Carbon Medical Technologies, Inc.
General & Plastic Surgery · 22d
Cleared Aug 21, 2003
ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID
K032377 · KHS
Roche Diagnostics Corp.
Chemistry · 20d
Cleared Aug 21, 2003
RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS
K032396 · JDI
Biomet, Inc.
Orthopedic · 17d
Cleared Aug 21, 2003
QSC-127 SHOULDER ARRAY COIL SET
K032429 · MOS
Mri Devices Corp.
Radiology · 15d
Cleared Aug 21, 2003
MODIFICATION TO: STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 & 100C-230
K032452 · GEI
Stellartech Research Corp.
General & Plastic Surgery · 10d
Cleared Aug 21, 2003
TOSHIBA EXCELART VANTAGE XGV/AGV MRI DIAGNOSTIC SYSTEM, MODELS MRT-1503/P3...
K032490 · LNH
Toshiba America Medical Systems, In.C
Radiology · 9d
Cleared Aug 21, 2003
ARTHROCARE SYSTEM
K032504 · GEI
Arthrocare Corp.
General & Plastic Surgery · 8d
Cleared Aug 20, 2003
MODIFICATION ORIA SPINAL SYSTEM
K023884 · KWP
Ortho Tec, LLC
Orthopedic · 272d
Cleared Aug 20, 2003
SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE
K023902 · FED
Usgi Medical, Inc.
Gastroenterology & Urology · 271d
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