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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
50497–50520 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 07, 2010
SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 MODEL: 863063, 863064, 863065,...
K101067 · MHX
Philips Medical Systems
Cardiovascular · 21d
Cleared May 06, 2010
MED CONTOUR
K091615 · IMI
General Project S.R.L.
Physical Medicine · 337d
Cleared May 06, 2010
A.B. KORKOR MEDICAL SKINNYSAFE INTRODUCER SHEATH
K092097 · DYB
A.B. Korkor Medical, Inc.
Cardiovascular · 296d
Cleared May 06, 2010
VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL...
K092467 · HAW
Brainlab AG
Neurology · 267d
Cleared May 06, 2010
PARI SINUS
K092560 · CAF
Pari Respiratory Equipment, Inc.
Anesthesiology · 259d
Cleared May 06, 2010
CAREVENT HANDHELD CPAP SYSTEM
K093862 · BTL
O-Two Medical Technologies, Inc.
Anesthesiology · 140d
Cleared May 06, 2010
BUSSE SURGICAL DRAPES IV
K093909 · KKX
Busse Hospital Disposables, Inc.
General Hospital · 135d
Cleared May 06, 2010
AEQUALIS REVERSED SHOULDER PROSTHESIS
K100142 · PHX
Tornier
Orthopedic · 107d
Cleared May 06, 2010
STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000
K100852 · OCS
Stryker Communications
Gastroenterology & Urology · 41d
Cleared May 06, 2010
SPECTRUM TURBO-JECT PICC SET
K100974 · FOZ
Cook Incorporated
General Hospital · 28d
Cleared May 05, 2010
POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA, GREEN COLOR
K092302 · LYZ
Bettercare Plastic Products Co., Ltd.
General Hospital · 280d
Cleared May 05, 2010
FORA G31A/TD-4256A BLOOD GLUCOSE MONITORING SYSTEM AND FORA G31B/TD-4256B...
K094005 · NBW
Taidoc Technology Corporation
Chemistry · 128d
Cleared May 05, 2010
SURGIQUEST ANCHORPORT SIL KIT
K100180 · GCJ
Surgiquest, Inc.
General & Plastic Surgery · 104d
Cleared May 05, 2010
EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT
K100187 · CGA
Medica Corp.
Chemistry · 103d
Cleared May 05, 2010
SLENDERTONE SYSTEM ULTRA MODEL E70/X70
K100320 · NGX
Bio-Medical Research, Ltd.
Physical Medicine · 90d
Cleared May 05, 2010
BIOLOX DELTA CERAMIC FEMORAL HEADS
K100412 · LZO
Smith & Nephew, Inc.
Orthopedic · 78d
Cleared May 05, 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
K100486 · LYZ
Zibo Yinghao Medical Products Co., Ltd.
General Hospital · 75d
Cleared May 05, 2010
CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B
K100508 · DRG
Carematix, Inc.
Cardiovascular · 72d
Cleared May 05, 2010
DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A
K100778 · JIX
Siemens Healthcare Diagnostics
Chemistry · 47d
Cleared May 05, 2010
M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
K100830 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 42d
Cleared May 05, 2010
PARIE TENE PROGRIP MESH
K101197 · FTL
Sofradim Production
General & Plastic Surgery · 7d
Cleared May 04, 2010
HEMOSIL F11 & FV DNA CONTROL
K093737 · NZB
Instrumentation Laboratory CO
Pathology · 151d
Cleared May 04, 2010
PASCAL STREAMLINE PHOTOCOAGULATOR
K100019 · HQF
Optimedica Corporation
Ophthalmic · 119d
Cleared May 04, 2010
SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150
K100139 · MSH
Safelife Corp.
General Hospital · 105d