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

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176,076 results
54433–54456 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 03, 2009
BLAZER DX-20 DIAGNOSTIC CATHETER
K081576 · DRF
Boston Scientific Corp
Cardiovascular · 243d
Cleared Feb 03, 2009
COULTER BODY FLUID CONTROL
K082162 · JPK
Beckman Coulter, Inc.
Hematology · 187d
Cleared Feb 03, 2009
DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS
K082400 · FIP
Culligan Soft Water Service Co.
Gastroenterology & Urology · 167d
Cleared Feb 03, 2009
MODIFICATION TO ULTRALIGHT II ND: YAG LASER SYSTEM
K082407 · GEX
Sandstone Medical Technologies, LLC
General & Plastic Surgery · 166d
Cleared Feb 03, 2009
SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER
K083002 · LKM
Sysmex America, Inc.
Pathology · 118d
Cleared Feb 03, 2009
ASAHI CORSAIR MICROCATHETER
K083127 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 105d
Cleared Feb 03, 2009
X-CAL
K083200 · KRX
Streck
Hematology · 96d
Cleared Feb 03, 2009
AIDERA DIASEND
K083221 · MRZ
Aidera AB
General Hospital · 95d
Cleared Feb 03, 2009
JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381
K083265 · NBW
Agamatrix, Inc.
Chemistry · 90d
Cleared Feb 03, 2009
CROSSOVER
K083269 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 90d
Cleared Feb 03, 2009
AVIVO MOBILE PATIENT MANAGEMENT SYSTEM
K083287 · DSI
Corventis, Inc.
Cardiovascular · 88d
Cleared Feb 03, 2009
MEDONIC M SERIES
K083420 · GKZ
Boule Medical AB
Hematology · 76d
Cleared Feb 03, 2009
MEDPOR CUSTOMIZED SURGICAL IMPLANT
K083621 · JOF
Porex Surgical, Inc.
Ear, Nose, Throat · 57d
Cleared Feb 02, 2009
VISION HOLLOW FIBER OXYGENATOR WITH HA COATING
K080708 · DTZ
Gish Biomedical, Inc.
Cardiovascular · 327d
Cleared Feb 02, 2009
CADSTREAM, VERSION 5.0
K081556 · LLZ
Confirma, Inc.
Radiology · 244d
Cleared Feb 02, 2009
LDR SPINE ROI INTERBODY FUSION SYSTEM
K082262 · MAX
Ldr Spine USA
Orthopedic · 178d
Cleared Feb 02, 2009
MS SYSTEM
K083067 · DZE
Osstem Implant Co., Ltd.
Dental · 110d
Cleared Feb 02, 2009
EQUASHIELD SYSTEM
K083152 · LHI
Plastmed, Ltd.
General Hospital · 101d
Cleared Feb 02, 2009
WILDCAT 7F GUIDEWIRE SUPPORT CATHETER
K083313 · DQY
Avinger, Inc.
Cardiovascular · 84d
Cleared Feb 02, 2009
CARDIFF ANTERIOR CERVICAL PLATE SYSTEM
K083338 · KWQ
Seaspine, Inc.
Orthopedic · 82d
Cleared Feb 02, 2009
IMMULITE 2000 FREE T4
K083373 · CEC
Siemens Healthcare Diagnostics, Inc.
Chemistry · 80d
Cleared Feb 02, 2009
KAT IMPLANT SYSTEM
K083544 · NHA
Kat Implants, LLC
Dental · 66d
Cleared Feb 02, 2009
NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336,...
K083667 · ITX
B-K Medical Aps
Radiology · 53d
Cleared Feb 02, 2009
MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 32041-20,...
K083711 · GEI
Barrx Medical, Incorporated
General & Plastic Surgery · 49d