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
65569–65592 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 29, 2005
BARRX HALO 360 SYSTEM, MODEL 1100C-115A
K051168 · GEI
Barrx Medical, Incorporated
General & Plastic Surgery · 55d
Cleared Jun 29, 2005
PUSHLOCK
K051219 · MAI
Arthrex, Inc.
Orthopedic · 48d
Cleared Jun 29, 2005
BTI-SCAN, VERSION 4.0
K051392 · LLZ
B.T.I. Biotechnology Institute, Sl.
Radiology · 33d
Cleared Jun 29, 2005
INTELIFUSE, INC. WARM SYSTEM WITH STIMULINKS
K051408 · JDR
Intelifuse, Inc.
Orthopedic · 29d
Cleared Jun 29, 2005
ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS
K051411 · LZO
Biomet, Inc.
Orthopedic · 29d
Cleared Jun 29, 2005
MODIFIED CONTACT-HEAT EVOKED POTENTIAL STIMULATOR (CHEPS)
K051448 · NTU
Medoc Ltd. Advanced Medical Systems
Neurology · 27d
Cleared Jun 29, 2005
CARDIODAY
K051471 · DQK
Getemed Medizin- Und...
Cardiovascular · 26d
Cleared Jun 29, 2005
JAN MAO WHEELCHAIR, MODEL JMC611-F18EPP
K051481 · IOR
Jan Mao Industries Co., Ltd.
Physical Medicine · 26d
Cleared Jun 29, 2005
JAN MAO WHEELCHAIR, MODEL JMC612-F18EPP
K051482 · IOR
Jan Mao Industries Co., Ltd.
Physical Medicine · 26d
Cleared Jun 29, 2005
ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
K051554 · KTT
Alliance Medical Corp.
Orthopedic · 16d
Cleared Jun 29, 2005
STAR 50 MONITORING SYSTEM
K051608 · MWI
Larsen & Toubro Limited
Cardiovascular · 12d
Cleared Jun 29, 2005
SUPER VIEW DISPOSABLE BIOM LENS SET
K051630 · HJK
Insight Instruments, Inc.
Ophthalmic · 12d
Cleared Jun 28, 2005
HBA1C ENZYMATIC ASSAY
K050178 · LCP
General Atomics
Chemistry · 153d
Cleared Jun 28, 2005
OPEN BREAST COIL (OBC) WITH BIOPSY PLATES
K050728 · MOS
Usa Instruments, Inc.
Radiology · 99d
Cleared Jun 28, 2005
MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES)
K050954 · HCG
MicroVention, Inc.
Neurology · 74d
Cleared Jun 28, 2005
VARELISA RECOMBI CTD SCREEN, MODEL 13096
K050967 · LJM
Sweden Diagnostics (Germany) GmbH
Immunology · 71d
Cleared Jun 28, 2005
IMAGEQUBE PACS
K051037 · LLZ
Intuitive Imaging Informatics, LLC
Radiology · 64d
Cleared Jun 28, 2005
AMSURE 100% SILICONE FOLEY CATHETER
K051059 · EZL
Amsino International, Inc.
Gastroenterology & Urology · 63d
Cleared Jun 28, 2005
CAC-127-8 CARDOAC ARRAY COIL
K051512 · MOS
Invivo Corp.
Radiology · 21d
Cleared Jun 28, 2005
REGIUS RS-1000, MEDICAL IMAGE PROCESSING WORKSTATION
K051521 · LLZ
Konica Minolta Medical & Graphic, Inc.
Radiology · 20d
Cleared Jun 28, 2005
MODIFICATION TO:REGISTRADO X-TRA
K051535 · ELW
Voco GmbH
Dental · 18d
Cleared Jun 28, 2005
SMALL INTESTINAL VIDEOSCOPE SYSTEM
K051551 · KNT
Olympus Medical Systems Corporation
Gastroenterology & Urology · 15d
Cleared Jun 28, 2005
NEXUS DETACHABLE COIL, MULTI-DIAMETER CSR AND HELIX SUPER SOFT CSR
K051560 · HCG
Micro Therapeutics, Inc.
Neurology · 15d
Cleared Jun 27, 2005
REVLIGHT SKIN CARE SYSTEM
K042630 · GEX
Skincare Technology, Inc.
General & Plastic Surgery · 273d