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
65593–65616 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 2005
CAPILLARY'S IMMUNOTYPING (PN 2100)
K042939 · DFH
Sebia, Inc.
Immunology · 245d
Cleared Jun 27, 2005
FES CYCLE ERGOMETER, MODEL RT300-S
K050036 · GZI
Restorative Therapies, Inc.
Neurology · 171d
Cleared Jun 27, 2005
FISHVIEW
K050236 · LNJ
Applied Spectral Imaging , Ltd.
Pathology · 147d
Cleared Jun 27, 2005
FREESTYLE 600 BLOOD GLUCOSE MONITORING SYSTEM
K050500 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 119d
Cleared Jun 27, 2005
CYNERGY MULTIPLEX LASER
K050779 · GEX
Cynosure, Inc.
General & Plastic Surgery · 91d
Cleared Jun 27, 2005
19-INCH (48 CM) COLOR LCD MONITOR CDL1902A
K051331 · LLZ
Totoku Electric Co., Ltd.
Radiology · 35d
Cleared Jun 24, 2005
SHL DISPOSABLE AUTOINJECTOR
K050434 · KZH
Shl Medical, USA
General Hospital · 122d
Cleared Jun 24, 2005
NXSTAGE SYSTEM ONE
K050525 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 114d
Cleared Jun 24, 2005
CORONARY SINUS DEFLECTABLE MAPPING CATHETER, 4 FR, 5 FR, 6 FR & 7 FR
K050877 · DRF
Biosense Webster, Inc.
Cardiovascular · 79d
Cleared Jun 24, 2005
ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA...
K050936 · LDJ
ACON Laboratories, Inc.
Toxicology · 71d
Cleared Jun 24, 2005
MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
K051088 · DKB
Lin-Zhi International, Inc.
Chemistry · 57d
Cleared Jun 24, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFEPIME (STREP) 0.0625-4UG/ML
K051204 · LON
Becton, Dickinson & CO
Microbiology · 44d
Cleared Jun 24, 2005
LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER
K051395 · DQO
Vascular Solutions, Inc.
Cardiovascular · 28d
Cleared Jun 24, 2005
MODIFICATION TO: CERCON BASE
K051462 · EIH
Dentsply Intl.
Dental · 21d
Cleared Jun 24, 2005
PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL)
K051464 · EHD
Planmeca Oy
Radiology · 21d
Cleared Jun 24, 2005
ZOLL M SERIES 12SL ANALYSIS OPTION
K051475 · MKJ
ZOLL Medical Corporation
Cardiovascular · 21d
Cleared Jun 24, 2005
BPCALIBRATOR MC3000/MC3100
K051546 · DXN
Healthstats International Pte. , Ltd.
Cardiovascular · 11d
Cleared Jun 23, 2005
SYNTHACER
K041177 · MQV
Medartis Medizinprodukte Und...
Orthopedic · 414d
Cleared Jun 23, 2005
ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50
K050424 · BZG
Fim Medical
Anesthesiology · 125d
Cleared Jun 23, 2005
750C SERIES MONITOR, MODELS 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL,...
K050844 · DQA
Cas Medical Systems, Inc.
Anesthesiology · 80d
Cleared Jun 23, 2005
XAWEX G 100
K050903 · EIH
Wieland Dental + Technik GmbH & Co. KG
Dental · 73d
Cleared Jun 23, 2005
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K051202 · JWY
Dade Behring, Inc.
Microbiology · 43d
Cleared Jun 23, 2005
JET BLUE BITE
K051243 · ELW
Coltene/Whaledent AG
Dental · 41d
Cleared Jun 23, 2005
MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE
K051283 · MSX
Cardiopulmonary Corp.
Cardiovascular · 37d