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
44353–44376 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 16, 2012
CLEARPATH UPPER GI
K113166 · FDS
Easyglide , Ltd.
Gastroenterology & Urology · 202d
Cleared May 16, 2012
APEX MEDICAL ICH CPAP SERIES (9S-007XXX)
K120035 · BZD
Apex Medical Corp.
Anesthesiology · 133d
Cleared May 16, 2012
PATIENT MONITOR
K120173 · MHX
Edan Instruments, Inc.
Cardiovascular · 117d
Cleared May 16, 2012
GENOSYL MV-1000
K120216 · MRN
Geno, LLC
Anesthesiology · 113d
Cleared May 16, 2012
TROJAN MAGNUM CONDOM WITH FIRE & ICE LUBRICANT
K120287 · HIS
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 106d
Cleared May 16, 2012
ARTHREX MIXING AND DELIVERY SYSTEM
K121124 · FMF
Arthrex, Inc.
General Hospital · 33d
Cleared May 16, 2012
VANGUARD SSK 360 REVISION KNEE SYSTEM
K121149 · JWH
Biomet Manufacturing Corp
Orthopedic · 30d
Cleared May 16, 2012
RADIAL JAW 4 PULMONARY BIOPSY FORCEPS
K121186 · BWH
Boston Scientific Corp
Ear, Nose, Throat · 28d
Cleared May 15, 2012
S 100 PEDICLE SCREW SYSTEM
K111940 · MNH
Renovis Surgical Technologies, LLC
Orthopedic · 312d
Cleared May 15, 2012
FILMARRAY RP PANEL
K120267 · OCC
Idaho Technology, Inc.
Microbiology · 106d
Cleared May 15, 2012
ADVIA CHEMISTRY GLUH_3 REAGENTS
K120681 · CFR
Siemens Healthcare Diagnostics, Inc.
Chemistry · 70d
Cleared May 15, 2012
SWITCH-IT CATHETER
K120707 · DQY
Vascular Solutions, Inc.
Cardiovascular · 68d
Cleared May 15, 2012
TL-200 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM
K121141 · DXN
Tensys Medical Systems, Inc.
Cardiovascular · 29d
Cleared May 15, 2012
QLAB WITH FHN AND VPQ PLUG-IN
K121223 · LLZ
Philips Ultrasound, Inc.
Radiology · 22d
Cleared May 14, 2012
COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123...
K111188 · CHL
Roche Diagnostics
Chemistry · 383d
Cleared May 14, 2012
TINA-QUANT ALBUMIN GEN.2
K113072 · DCF
Roche Diagnostics Operations
Toxicology · 210d
Cleared May 14, 2012
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR
K113194 · LYZ
Suqian Ruijang Medical Supplies Co.,...
General Hospital · 196d
Cleared CT May 14, 2012
MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY
K113215 · MUD
Nonin Medical, Inc.
Cardiovascular · 195d
Cleared May 14, 2012
GEL-BLOCK EMBOLIZATION PLEDGETS
K113266 · KRD
Vascular Solutions, Inc.
Cardiovascular · 192d
Cleared May 14, 2012
COMED K-SERIES MANUAL WHEELCHAIR
K120077 · IOR
Danyang Comed Healthcare Co., Ltd.
Physical Medicine · 125d
Cleared May 14, 2012
ROCAMED ROCAUS PLATINUM
K120160 · KNY
Promepla Sam
Gastroenterology & Urology · 116d
Cleared May 14, 2012
COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM
K120166 · IRP
Won Industrial Co.
Physical Medicine · 116d
Cleared CT May 14, 2012
MLS, ZERONA-AD
K120257 · OLI
Erchonia Medical, Inc.
General & Plastic Surgery · 108d
Cleared May 14, 2012
EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL
K120497 · LCP
Medica Corp.
Chemistry · 83d