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
45937–45960 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 2011
SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS
K111323 · KKY
Synthes, Inc.
General & Plastic Surgery · 189d
Cleared Nov 16, 2011
RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE
K111773 · NLF
Renu Medical, Inc.
Anesthesiology · 146d
Cleared Nov 16, 2011
MEDLINE PNEUMOPERITONEUM NEEDLE
K111955 · HIF
Medline Industries, Inc.
Obstetrics & Gynecology · 128d
Cleared Nov 16, 2011
SOYALA SILKGEL FULL FACE MASK
K112167 · BZD
Weinmann Gerate Fur Medizin GmbH +...
Anesthesiology · 111d
Cleared Nov 16, 2011
SNORERX 9.0
K112205 · LRK
Consumer Health Products, Inc.
Dental · 107d
Cleared Nov 16, 2011
VIZION
K112276 · JWY
Trek Diagnostic Systems
Microbiology · 99d
Cleared Nov 16, 2011
STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM, STRAUMANN CARES DOLDER BAR...
K112280 · NHA
Straumann USA
Dental · 99d
Cleared Nov 16, 2011
TASMAN
K112393 · BZD
Resmed, Ltd.
Anesthesiology · 89d
Cleared Nov 16, 2011
THE BELMONT BUDDY LITE FLUID WARMER
K112639 · BSB
Belmont Instrument Corp.
Hematology · 65d
Cleared Nov 16, 2011
HYPERELASTIC WIRE
K112640 · DZC
Ormco Corp.
Dental · 65d
Cleared Nov 16, 2011
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K113195 · LYZ
Suqian Ruijang Medical Supplies Co.,...
General Hospital · 16d
Cleared Nov 16, 2011
DENTAL LASER THERAPY SYSTEM
K113212 · GEX
China Daheng Group, Inc.
General & Plastic Surgery · 15d
Cleared Nov 15, 2011
ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL
K111005 · DIC
Medica Corp.
Toxicology · 218d
Cleared Nov 15, 2011
REPROCESSED HAND ACTIVATE SEALER/DIVIDER
K111600 · NUJ
Ascent Healthcare Solutions
General & Plastic Surgery · 160d
Cleared Nov 15, 2011
RSP GLENOID BASEPLATE POROUS COATED
K112069 · PHX
Encore Medical, L.P.
Orthopedic · 118d
Cleared Nov 15, 2011
ANATOMIC PEEK CERVICAL FUSION SYSTEM
K112444 · ODP
Medtronic Sofamor Danck USA, Inc.
Orthopedic · 83d
Cleared Nov 15, 2011
STERISPINEPS PEDICLE SCREW
K112453 · NKB
Safe Orthopaedics
Orthopedic · 82d
Cleared Nov 15, 2011
SONOSITE EDGE ULTRASOUND SYSTEM
K113156 · IYO
Sonosite,Inc.
Radiology · 20d
Cleared Nov 14, 2011
FUZE: INTRAMEDULLARY INTERNAL FIXATION NAIL
K102413 · HSB
Vilex, Inc.
Orthopedic · 447d
Cleared Nov 14, 2011
EMERGE FRACTIONAL LASER
K111840 · ONG
Palomar Medical Products, Inc.
General & Plastic Surgery · 138d
Cleared Nov 14, 2011
ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM
K111843 · OLO
Smith & Nephew Inc., Endoscopy Div.
Orthopedic · 138d
Cleared Nov 14, 2011
ACU-SINCH REPAIR SYSTEM AND ACUMED SUTURE ANCHOR
K112111 · HTN
Acumed, LLC
Orthopedic · 112d
Cleared Nov 14, 2011
PERI-LOC PROXIMAL FEMUR LOCKING BONE PLATES
K112406 · HRS
Smith & Nephew, Inc.
Orthopedic · 84d
Cleared Nov 14, 2011
VARIAN HIGH ENERGY LINEAR ACCELERATOR
K112839 · IYE
Varian Medical Systems
Radiology · 47d