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
53545–53568 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 15, 2009
MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT
K082403 · DTZ
Gish Biomedical, Inc.
Cardiovascular · 267d
Cleared May 15, 2009
LOTUS II PULSED ER: YAG LASER SYSTEM
K083253 · GEX
Laseroptek Co., Ltd.
General & Plastic Surgery · 192d
Cleared May 15, 2009
ZIEHM VISION RFD
K083545 · OWB
Ziehm Imaging, Inc.
Radiology · 168d
Cleared May 15, 2009
INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022
K083851 · LHI
Inviro Medical Devices, Inc.
General Hospital · 142d
Cleared May 15, 2009
POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN...
K090066 · KGO
Wear Safe Malaysia Sdn. Bhd.
General Hospital · 126d
Cleared May 15, 2009
SPECTRA SYSTEM DENTAL IMPLANTS 2008
K090234 · DZE
Implant Direct, LLC
Dental · 105d
Cleared May 15, 2009
BRAVO AUTOCLAVE, MODELS 17, 17V AND 21V
K090265 · FLE
Scican , Ltd.
General Hospital · 101d
Cleared May 15, 2009
BACKSTOP CATHETER, MODEL 60-0000-3100
K090270 · KOD
Pluromed, Inc.
Gastroenterology & Urology · 100d
Cleared May 15, 2009
CD HORIZON SPINAL SYSTEM
K090390 · NKB
Medtronic Sofamor Danek
Orthopedic · 87d
Cleared May 15, 2009
EPICARDIA 5000
K090834 · DSI
Medicomp, Inc.
Cardiovascular · 49d
Cleared May 15, 2009
AMIGO CATEGORY III FULL-SIZED REGULAR DUTY 3 WHEEL (310000) AND AMIGO...
K090966 · INI
Svrc Industries, Inc.
Physical Medicine · 39d
Cleared May 15, 2009
RESPIRONICS SLEEPEASY CPAP SYSTEM
K091112 · BZD
Respironics, Inc.
Anesthesiology · 28d
Cleared May 15, 2009
MODIFICATION TO THE CROSSER SYSTEM
K091119 · PDU
Flowcardia, Inc.
Cardiovascular · 28d
Cleared May 15, 2009
SYNGO US WORKPLACE
K091286 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared May 15, 2009
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0
K091295 · ITX
Toshiba America Medical Systems, In.C
Radiology · 11d
Cleared May 14, 2009
AONGEN COLLAGEN MATRIX
K080868 · KGN
Aeon Astron Europe B.V.
General & Plastic Surgery · 412d
Cleared May 14, 2009
BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER
K081130 · DQY
Bridgepoint Medical
Cardiovascular · 388d
Cleared CT May 14, 2009
TEARLAB OSMOLARITY SYSTEM
K083184 · OND
Ocusense, Inc.
Chemistry · 198d
Cleared May 14, 2009
MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B
K083385 · BTL
Allied Healthcare Products, Inc.
Anesthesiology · 178d
Cleared May 14, 2009
GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL
K083648 · HSB
Efratgo, Ltd. HI Tech Bio-Surgical
Orthopedic · 156d
Cleared May 14, 2009
VITAL SIGNS MONITOR
K083821 · DQA
Edan Instruments, Inc.
Anesthesiology · 143d
Cleared May 14, 2009
BREAS VIVO 40 SYSTEM
K090113 · MNT
Breas Medical AB
Anesthesiology · 113d
Cleared CT May 14, 2009
A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT,...
K090413 · LCP
Bayer Healthcare, LLC
Chemistry · 85d
Cleared May 14, 2009
DVX SPINE SYSTEM
K090424 · MNH
Bk Meditech, Co., Ltd.
Orthopedic · 84d