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
68257–68280 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 27, 2004
SURFIX KNEE OSTEOTOMY SYSTEM
K041601 · HRS
Surfix Technologies
Orthopedic · 74d
Cleared Aug 27, 2004
B. BRAUN BICARBONATE DIALYSATE
K041683 · KPO
B.Braun Medical, Inc.
Gastroenterology & Urology · 67d
Cleared Aug 27, 2004
RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULE
K041997 · MUJ
Radionics, A Division of Tyco...
Radiology · 32d
Cleared Aug 27, 2004
ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222
K042005 · NBW
Taidoc Technology Corporation
Chemistry · 32d
Cleared Aug 27, 2004
NXSTAGE PUREFLOW-B SOLUTION
K042045 · KPO
Nxstage Medical, Inc.
Gastroenterology & Urology · 28d
Cleared Aug 27, 2004
ENDOTINE FOREHEAD TRIPLE DEVICE
K042078 · HWC
Coapt Systems, Inc.
Orthopedic · 25d
Cleared Aug 27, 2004
CASHMERE POWDER FREE NITRILE EXAMINATION GLOVES
K042101 · LZA
Seal Polymer Industries Bhd.
General Hospital · 23d
Cleared Aug 27, 2004
PICC
K042126 · LJS
Arrow Intl., Inc.
General Hospital · 21d
Cleared Aug 27, 2004
XLTEK TREX MODEL#10309
K042150 · GWQ
Excel Tech. , Ltd.
Neurology · 18d
Cleared Aug 27, 2004
MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM
K042177 · DPS
Ge Medical Systems Information...
Cardiovascular · 16d
Cleared Aug 26, 2004
TIDAL WAVE SP MODEL 710/715 AND 715
K032971 · DQA
Respironics Novametrix, Inc.
Anesthesiology · 339d
Cleared Aug 26, 2004
STORZ MODULITH, MODEL SLX-F2
K040476 · LNS
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 184d
Cleared Aug 26, 2004
AIS100 AUTOMATIC INTRAMUSCULAR STIMULATOR
K040580 · NRW
D.Y. Instrument, Inc.
General Hospital · 175d
Cleared Aug 26, 2004
URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS
K040703 · JIO
Dirui Industrial Co., Ltd.
Chemistry · 162d
Cleared Aug 26, 2004
RINSPIRATION SYSTEM,RINSPIRATION SYSTEM SHORT TIP, MODELS FG01477/FG01703
K041123 · DQO
Kerberos Proximal Solutions, Inc.
Cardiovascular · 118d
Cleared Aug 26, 2004
LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM
K041419 · GEX
Medical Energy, Inc.
General & Plastic Surgery · 90d
Cleared Aug 26, 2004
NAME BONE VOID FILLER
K041421 · MQV
Stryker Biotech
Orthopedic · 90d
Cleared Aug 26, 2004
ANKYLOS DENTAL IMPLANT SYSTEM
K041509 · DZE
Friadent GmbH
Dental · 80d
Cleared Aug 26, 2004
AUTOFUSER AMBULATORY INFUSION PUMP
K041585 · MEB
Algos, LC
General Hospital · 73d
Cleared Aug 26, 2004
NOBEL BIOCARE ENDOSSEOUS IMPLANTS
K041661 · DZE
Nobel Biocare Uas, Inc.
Dental · 69d
Cleared Aug 26, 2004
ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304
K041711 · KGW
Applied Medical Resources Corp.
General & Plastic Surgery · 64d
Cleared Aug 26, 2004
SABRESOURCE DRAPE
K041846 · KKX
Minrad, Inc.
General Hospital · 49d
Cleared Aug 26, 2004
MAMMOSITE II RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER...
K041929 · JAQ
Proxima Therapeutics, Inc.
Radiology · 38d
Cleared Aug 26, 2004
OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATION
K041931 · OWB
Ge Oec Medical Systems, Inc.
Radiology · 38d