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
50305–50328 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 03, 2010
AESKU PR3
K091859 · MOB
Aesku Diagnostics
Immunology · 349d
Cleared Jun 03, 2010
GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT
K092667 · MQL
Intl., Inc.
Obstetrics & Gynecology · 276d
Cleared Jun 03, 2010
AMBULATORY BLOOD PRESSURE MONITOR, MODELS FB-270 AND DS-270
K093102 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 245d
Cleared Jun 03, 2010
CARECENTER MD
K093211 · DPS
Cardiac Science Corporation
Cardiovascular · 233d
Cleared Jun 03, 2010
BIODENTA DENTAL IMPLANT SYSTEM
K093630 · DZE
Biodenta Swiss AG
Dental · 192d
Cleared Jun 03, 2010
HOTDOG MULTI FUNCTION CONTROLLER
K094056 · DWJ
Augustine Biomedical & Design, LLC
Cardiovascular · 154d
Cleared Jun 03, 2010
PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE
K100546 · BTR
Parkermedicalinc
Anesthesiology · 98d
Cleared Jun 03, 2010
BD INTIMA II CLOSED IV CATHETER
K100775 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 77d
Cleared Jun 03, 2010
ULTICARE DISPOSABLE PEN NEEDLES
K100812 · FMI
Ultimed, Inc.
General Hospital · 72d
Cleared Jun 03, 2010
SYLE SMARTIP
K100833 · EFB
Osspray, Ltd.
Dental · 71d
Cleared Jun 03, 2010
MODIFICATION TO HBS HEADLESS BONE SCREW
K101030 · HWC
Biopro, Inc.
Orthopedic · 51d
Cleared Jun 03, 2010
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020
K101297 · OTM
Coloplast A/S
Gastroenterology & Urology · 24d
Cleared Jun 02, 2010
CLYDESDALE SPINAL SYSTEM
K100175 · MAX
Medtronic Sofamor Danek
Orthopedic · 132d
Cleared Jun 02, 2010
GEON RAPID DIGITAL THERMOMETER MODEL: MT-B117, MT-B127, MT-B130, MT-B132FA
K100563 · FLL
Geon Corporation
General Hospital · 93d
Cleared Jun 02, 2010
MALTA
K100756 · EMA
3M Espe AG Dental Products
Dental · 77d
Cleared Jun 02, 2010
HYDROFIX SURGICAL SHEET
K100905 · OMR
Mimedx Group, Inc.
Cardiovascular · 62d
Cleared Jun 02, 2010
JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100
K101221 · MCW
Pathway Medical Technologies, Inc.
Cardiovascular · 30d
Cleared Jun 02, 2010
VIEWFLEX PLUS ICE CATHETER
K101239 · DQO
St Jude Medical
Cardiovascular · 30d
Cleared Jun 01, 2010
TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX...
K091281 · HEB
Procter & Gamble Co.
Obstetrics & Gynecology · 396d
Cleared Jun 01, 2010
XPERT MRSA/SA NASAL ASSAY
K100822 · NQX
Cepheid
Microbiology · 70d
Cleared May 28, 2010
NON-INVASIVE INFRARED (NIR)
K090386 · FLL
Medisim, Ltd.
General Hospital · 465d
Cleared May 28, 2010
SCENAR, MODEL 10
K092117 · GZJ
Ritm Okb Zao
Neurology · 318d
Cleared May 28, 2010
SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX
K092608 · MQV
Collagen Matrix, Inc.
Orthopedic · 276d
Cleared May 28, 2010
ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT,...
K092704 · LSK
Abbott Molecular, Inc.
Microbiology · 267d