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
54361–54384 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 10, 2009
HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER
K082129 · CFN
The Binding Site, Ltd.
Immunology · 196d
Cleared Feb 10, 2009
DLMS-ZIRBLOCKS
K082137 · EIH
Dental Milling Laboratory Supplies...
Dental · 196d
Cleared Feb 10, 2009
N-DEX BWC PINK NITRILE MEDICAL EXAMINATION GLOVE, NON STERILE
K082428 · LZA
Best Glove, Inc.
General Hospital · 172d
Cleared Feb 10, 2009
FLUOROCORE 2
K083326 · EBF
Dentsply International, Inc.
Dental · 90d
Cleared Feb 10, 2009
CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A...
K083468 · NBW
I-Sens, Inc.
Chemistry · 78d
Cleared Feb 10, 2009
POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES
K083624 · LZA
Comfort Rubber Gloves Ind. Sdn. Bhd.
General Hospital · 64d
Cleared Feb 10, 2009
HALO ABLATION CATHETER
K083737 · GEI
Barrx Medical, Incorporated
General & Plastic Surgery · 56d
Cleared Feb 10, 2009
HUMANSCAN M5S-D ULTRASOUND TRANSDUCER
K083824 · ITX
Humanscan Company, Ltd.
Radiology · 50d
Cleared Feb 10, 2009
EQUISTREAM LONG-TERM HEMODIALYSIS CATHETERS
K090101 · MSD
C.R. Bard, Inc.
Gastroenterology & Urology · 26d
Cleared Feb 10, 2009
BLOOD TUBING SETS (STERILE FLUID PATH)
K090255 · FJK
Nxstage Medical, Inc.
Gastroenterology & Urology · 8d
Cleared Feb 09, 2009
SMITH & NEPHEW SL-PLUS MIA STANDARD AND LATERAL FEMORAL HIP STEM
K082371 · LZO
Smith & Nephew, Inc.
Orthopedic · 175d
Cleared Feb 09, 2009
TENSCARE ITOUCH MODEL(S) EASY AND PLUS
K082377 · GZJ
Tenscare, Ltd.
Neurology · 175d
Cleared Feb 09, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K082690 · LYZ
Hebei Handform Plastic Products Co.,...
General Hospital · 147d
Cleared Feb 09, 2009
STIMPRO, MODELS SP22050, SP20100, SPP19050, SPP19100, SPP19150, SPC19050,...
K082772 · BSP
Life-Tech, Inc.
Anesthesiology · 140d
Cleared Feb 09, 2009
MASTERGRAFT RESORBABLE CERAMIC GRANULES
K082918 · MQV
Medtronic Sofamor Danek
Orthopedic · 132d
Cleared Feb 09, 2009
BIOPSY SCIENCES, INC., HYDROMARK BREAST BIOPSY SITE MARKER
K083006 · NEU
Biopsy Sciences, LLC
General & Plastic Surgery · 124d
Cleared Feb 09, 2009
MODIFICATION TO DEPUY NEUFLEX PIP FINGER
K083107 · KYJ
DePuy Orthopaedics, Inc.
Orthopedic · 112d
Cleared Feb 09, 2009
COMPEX SPORT PLUS
K083140 · NGX
Chattanooga Group
Physical Medicine · 109d
Cleared Feb 09, 2009
INTRAMEDULLARY FIXATION ROD (IFS)
K083458 · HSB
Novalign Orthopaedics, Inc.
Orthopedic · 80d
Cleared Feb 06, 2009
EQ-PRC LC WARFARIN GENOTYPING KIT
K073071 · ODW
Trimgen Corporation
Toxicology · 464d
Cleared Feb 06, 2009
STANDARD WHEELCHAIR PLATFORM
K073565 · INO
Design Specific , Ltd.
Physical Medicine · 415d
Cleared Feb 06, 2009
BRIDGEPOINT MEDICAL STINGRAY DEVICE AND ACCESSORIES
K080987 · DQY
Bridgepoint Medical
Cardiovascular · 305d
Cleared Feb 06, 2009
ADVANCED MEDICAL INNOVATIONS DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIES
K081398 · GEI
Advanced Medical Innovations, Inc.
General & Plastic Surgery · 263d
Cleared Feb 06, 2009
MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP
K081463 · HGX
Medel S.P.A.
Obstetrics & Gynecology · 259d