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
40825–40848 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 11, 2013
HEARTSINE SAMARITAN PAD 350P
K123881 · MKJ
Heartsine Technologies, Inc.
Cardiovascular · 206d
Cleared Jul 11, 2013
QUASAR C100, BABY QUASAR PLUS, QUASAR MD PLUS
K130225 · OHS
Silverbay, LLC, D/B/A Quasar Bio-Tech
General & Plastic Surgery · 163d
Cleared Jul 11, 2013
CLINICAL ALERT NOTIFICATION
K130339 · MSX
Extension , Inc.
Cardiovascular · 150d
Cleared Jul 11, 2013
STIMEL-03
K130424 · IPF
Stimel, Ltd.
Physical Medicine · 141d
Cleared Jul 11, 2013
NXSTAGE DOSING CALCULATOR
K130460 · FKP
Nxstage Medical, Inc.
Gastroenterology & Urology · 139d
Cleared Jul 11, 2013
ETCH GEL
K131248 · KLE
Dmg America, LLC
Dental · 71d
Cleared Jul 11, 2013
MONTERIS MEDICAL NEUROBLATE SYSTEM
K131278 · GEX
Monteris Medical, Inc.
General & Plastic Surgery · 66d
Cleared Jul 11, 2013
NEXUS HEMORRHOID LIGATOR
K131282 · FHN
Inx Medical
Gastroenterology & Urology · 66d
Cleared Jul 11, 2013
NEXUS ANTERIOR CERVICAL PLATE SYSTEM
K131520 · KWQ
Core-Nexus
Orthopedic · 44d
Cleared Jul 10, 2013
FUSEFORCE IMPLANT SYSTEM
K124045 · JDR
Solana Surgical, LLC
Orthopedic · 191d
Cleared Jul 10, 2013
QDC-PRO, AND NOX-RIP
K124062 · MNR
Nox Medical
Anesthesiology · 191d
Cleared CT Jul 10, 2013
EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA...
K130391 · LOX
Boston Scientific Corp
Cardiovascular · 145d
Cleared Jul 10, 2013
AIGIS RX N MEDIUM
K131007 · FTL
Tyrx, Inc.
General & Plastic Surgery · 90d
Cleared Jul 10, 2013
DLP CORONARY OSTIAL PERFUSION CANNULAE
K131269 · DWF
Medtronic, Inc.
Cardiovascular · 68d
Cleared Jul 10, 2013
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML)
K131331 · LON
Becton, Dickinson & CO
Microbiology · 62d
Cleared Jul 10, 2013
DERMA HOOD
K131338 · PEQ
Globalmedia Group, LLC
General Hospital · 62d
Cleared Jul 10, 2013
BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)
K131496 · DWL
Bsn Medical, Inc.
General Hospital · 48d
Cleared Jul 10, 2013
IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND...
K131738 · DHB
Phadia AB
Immunology · 27d
Cleared Jul 09, 2013
STATSEAL DISC
K130324 · QSY
Biolife, LLC
General & Plastic Surgery · 151d
Cleared Jul 09, 2013
NEXUS IV TUBING SET WITH LUER-ACCESSBILE ONE-WAY CHECK VALVE - IV PLUS
K130879 · FPA
Nexus Medical, LLC
General Hospital · 102d
Cleared Jul 09, 2013
ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC...
K131072 · OCY
Coloplast A/S
Gastroenterology & Urology · 83d
Cleared Jul 08, 2013
AMBIO REMOTE HEALTH MONITORING SYSTEM
K130676 · DRG
Arrayent Health, LLC D/B/A Ambio Health
Cardiovascular · 118d
Cleared Jul 08, 2013
WRIST AUTOMATIC BLOOD PRESSURE MONITOR
K131463 · DXN
Honsun (Nantong) Co., Ltd.
Cardiovascular · 48d
Cleared Jul 07, 2013
SFI BAR ABUTMENTS
K130183 · NHA
Sterngold Dental, LLC
Dental · 163d