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
38281–38304 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 05, 2014
HALO MEDICAL TECHNOLOGIES CATALYST MIDCRYSTL HALO ULTRASOUND SYSTEM
K140899 · IYO
Halo Medical Technologies, LLC
Radiology · 27d
Cleared May 02, 2014
NPWT WOUND DRESSING KIT- MEDIUM, NPWT WOUND DRESSING KIT- LARGE
K132004 · OMP
Creo Quality, LLC
General & Plastic Surgery · 305d
Cleared May 02, 2014
ACCUTORR 7 VITAL SIGNS MONITOR
K132038 · MWI
Mindray North America
Cardiovascular · 305d
Cleared May 02, 2014
I-CHROMA IFOB WITH I-CHROMA READER
K132167 · OOX
Boditech Med, Inc.
Hematology · 294d
Cleared May 02, 2014
SHARPS CONTAINER
K132476 · MMK
Grp & Associates
General Hospital · 267d
Cleared CT May 02, 2014
PULMONE MINIBOX PFT TM
K133051 · BZC
Pulmone Advanced Medical Devices, Ltd.
Anesthesiology · 217d
Cleared May 02, 2014
MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE...
K133064 · DQA
Envitec-Wismar GmbH
Anesthesiology · 217d
Cleared May 02, 2014
NUVASIVE EMG ENDOTRACHEAL TUBE
K133530 · PDQ
Nu Vasive, Incorporated
Neurology · 168d
Cleared May 02, 2014
MATRIXRIB FIXATION SYSTEM
K133616 · HRS
Synthes USA Products, LLC
Orthopedic · 158d
Cleared May 02, 2014
MANUKA FOAM HC, MANUKA FOAM HC (WITH ACRYLIC ADHESIVE BORDER), MANUKA FOAM HC...
K133934 · FRO
Links Medical Products, Inc.
General & Plastic Surgery · 130d
Cleared May 02, 2014
GIGALASER
K134017 · ILY
Powermedic Aps
Physical Medicine · 123d
Cleared May 02, 2014
SWIFT-LOCK ANCHOR
K140272 · GZB
St Jude Medical
Neurology · 88d
Cleared May 02, 2014
FILMARRAY GASTROINTESTINAL (GI) PANEL
K140407 · PCH
Biofire Diagnostics
Microbiology · 73d
Cleared May 02, 2014
PROPELLER SYSTEM - MODEL 2
K140638 · CAF
Reciprocal Labs Corporation
Anesthesiology · 51d
Cleared May 02, 2014
BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPS
K140856 · KXK
C.R. Bard, Inc.
Radiology · 29d
Cleared May 01, 2014
SILVERLON ISLAND WOUND DRESSING
K122817 · FRO
Argentum Medical, LLC
General & Plastic Surgery · 594d
Cleared May 01, 2014
SUSTAIN
K131866 · HIS
Hollender Sustainable Brands, LLC
Obstetrics & Gynecology · 311d
Cleared May 01, 2014
STABILIZATION SCREW
K131920 · HWC
In2bones Sas
Orthopedic · 309d
Cleared May 01, 2014
OEC 9800 PLUS
K132027 · OWB
Ge Oec Medical Systems, Inc.
Radiology · 304d
Cleared May 01, 2014
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
K132637 · LYZ
Zibo Intco Medical Products Co., Ltd.
General Hospital · 251d
Cleared May 01, 2014
RESPIRATORY GAS HUMIDIFIER
K132857 · BTT
Pacific Medico Co., Ltd.
Anesthesiology · 231d
Cleared May 01, 2014
COLLACARE DENTAL
K133290 · KGN
Innocoll Pharmaceuticals
General & Plastic Surgery · 188d
Cleared May 01, 2014
INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM
K133418 · MAX
Seaspine, Inc.
Orthopedic · 175d
Cleared May 01, 2014
XCAGE INTERBODY FUSION SYSTEM
K133514 · MAX
Ouroboros Medical
Orthopedic · 167d