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
66265–66288 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 07, 2005
BD POSIFLOW POSITIVE DISPLACEMENT VALVE
K050207 · FPA
Becton Dickinson Infusion Therapy...
General Hospital · 69d
Cleared Apr 07, 2005
HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM
K050225 · DQK
Cambridge Heart, Inc.
Cardiovascular · 65d
Cleared Apr 07, 2005
PROWIN
K050376 · LLZ
Medical Technologies International, Inc.
Radiology · 52d
Cleared Apr 07, 2005
NBD HEAD SCREW
K050377 · HAW
New Business Development, LLC
Neurology · 51d
Cleared Apr 07, 2005
BICON ORTHODONTIC IMPLANT SYSTEM
K050408 · DZE
Bicon, Inc.
Dental · 49d
Cleared Apr 07, 2005
20.8-INCH(53CM) MONOCHROME LCD MONITOR MDL2110A (ME351I), (DV3MM-HB)
K050485 · LLZ
Totoku Electric Co., Ltd.
Radiology · 41d
Cleared Apr 07, 2005
POWDER FREE NITRILE EXAMINATION GLOVE WITH TESTED FOR USE WITH CHEMOTHERAPY...
K050598 · LZA
Smart Glove Corp. Sdn Bhd
General Hospital · 29d
Cleared Apr 07, 2005
ALTAIRE
K050602 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 29d
Cleared Apr 07, 2005
NVA-127-8-A NEUROVASCULAR ARRAY COIL
K050621 · MOS
Mri Devices Corporation
Radiology · 28d
Cleared Apr 07, 2005
ANSPACH COUPLER
K050628 · HBE
The Anspach Effort, Inc.
Neurology · 27d
Cleared Apr 07, 2005
ZYGOMA TIUNITE
K050641 · NHA
Nobel Biocare USA, LLC
Dental · 24d
Cleared Apr 07, 2005
SPOR-TEST PA BIOLOGICAL INDICATOR KIT
K050664 · FRC
Getinge USA, Inc.
General Hospital · 23d
Cleared Apr 07, 2005
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168JT
K050711 · DXN
Health & Life Co., Ltd.
Cardiovascular · 20d
Cleared Apr 07, 2005
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168GA, HL168GS
K050714 · DXN
Health & Life Co., Ltd.
Cardiovascular · 20d
Cleared Apr 06, 2005
DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES
K043539 · GAM
Demetech Corp.
General & Plastic Surgery · 105d
Cleared Apr 06, 2005
SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL)
K050606 · DZL
Synthes (Usa)
Dental · 27d
Cleared Apr 06, 2005
ENDOTINE RIBBON
K050611 · GAM
Coapt Systems, Inc.
General & Plastic Surgery · 28d
Cleared Apr 06, 2005
SPOTCHEM II CREATININE, AMYLASE & ALP TESTS
K050652 · CGX
Arkray, Inc.
Chemistry · 23d
Cleared Apr 06, 2005
TEGRESS IMPLANT NEEDLE
K050688 · FBK
C.R. Bard, Inc.
Gastroenterology & Urology · 20d
Cleared Apr 06, 2005
MICROWARE 200
K050740 · GZJ
Microware, Inc.
Neurology · 15d
Cleared Apr 06, 2005
LC BRACKET ADHESIVE SYSTEM
K050750 · DYH
Dentsply Intl.
Dental · 14d
Cleared Apr 06, 2005
MODIFICATION TO BVBLUE
K050755 · MXB
Gryphus Diagnostics, LLC
Chemistry · 14d
Cleared Apr 05, 2005
DUREX SPEARMINT SCENTED LUBRICATED LATEX CONDOM (DUREX 'TINGLING PLEASURE'...
K042470 · HIS
Ssl Americas, Inc.
Obstetrics & Gynecology · 204d
Cleared Apr 05, 2005
OMRON DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N
K042505 · DXN
Omron Healthcare, Inc.
Cardiovascular · 202d