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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
160129–160152 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 19, 1982
PRO-SPEC
K822084 · HIB
Exitec, Inc.
Obstetrics & Gynecology · 37d
Cleared Aug 19, 1982
SURGICAL INSTRUMENTS REPRESENT. 4 CLASS
K822151 · HNF
Robert I. Chien & Assoc., Inc.
Ophthalmic · 28d
Cleared Aug 19, 1982
CATH-SEAL
K822247 · DYB
Universal Medical Instrument Corp.
Cardiovascular · 21d
Cleared Aug 19, 1982
ROYAL 1 OXYGEN CONCENTRATOR
K822301 · CAW
Proto-Med, Inc.
Anesthesiology · 16d
Cleared Aug 19, 1982
KAMPNER FEMORAL COMPONENT
K822320 · KWL
Intermedics Orthopedics
Orthopedic · 16d
Cleared Aug 19, 1982
BEHIND-THE-EAR MODEL SERIES 123
K822387 · ESD
Danavox, Inc.
Ear, Nose, Throat · 10d
Cleared Aug 16, 1982
POWERED MUSCLE STIMULATOR
K821511 · EPF
High Country Ent.
Ear, Nose, Throat · 88d
Cleared Aug 16, 1982
EXACON THERMOMETER SYSTEM 8000
K821555 · FLL
Sat Export Engineering & Trading
General Hospital · 83d
Cleared Aug 16, 1982
EXACON TEMP. PROBES SYSTEM 8000-#TH-103
K821556 · FLL
Sat Export Engineering & Trading
General Hospital · 83d
Cleared Aug 16, 1982
PHOTOTHERAPY EYE PROTECTION FOR INFANTS
K821765 · HOY
Russell Terry Co.
Ophthalmic · 63d
Cleared Aug 16, 1982
I.V. SENTINEL
K821823 · FLN
The John Bunn Co.
General Hospital · 55d
Cleared Aug 16, 1982
SECHRIST MODEL 990 JET VENTILATOR
K821930 · CBK
Sechrist Industries, Inc.
Anesthesiology · 48d
Cleared Aug 16, 1982
CRITIKON OXYGEN MONITOR, MODEL 8030
K821936 · KLK
Critikon Company, LLC
Anesthesiology · 48d
Cleared Aug 16, 1982
TITAN GEL SERUM CONTROL
K821982 · JJY
Helena Laboratories
Chemistry · 41d
Cleared Aug 16, 1982
MEDI + BIO SAFE STEAM STERILIZ. INDICAT
K821997 · JOJ
Arvey Corp.
General Hospital · 40d
Cleared Aug 16, 1982
LARGE VOLUME CLOSED WOUND SUCTION DRAIN
K822032 · GCY
American Heyer Schulte
General & Plastic Surgery · 35d
Cleared Aug 16, 1982
LUNDIA 10-5 N PARALLEL FLOW DIALYZER
K822049 · KOC
Gambro, Inc.
Gastroenterology & Urology · 35d
Cleared Aug 16, 1982
KAM SUCKER
K822065 · KDC
The Anspach Effort, Inc.
General & Plastic Surgery · 33d
Cleared Aug 16, 1982
U-100 INSULIN SYRINGE
K822083 · FMF
Terumo Medical Corp.
General Hospital · 35d
Cleared Aug 16, 1982
DENTAL MATRIX BAND
K822094 · DZN
Dentsply Intl.
Dental · 31d
Cleared Aug 16, 1982
ANESTHESIA BREATHING BAG, VARIOUS SIZES
K822116 · BTC
Life Design Systems, Inc.
Anesthesiology · 28d
Cleared Aug 16, 1982
LASER BRONCHOSCOPE
K822136 · EOQ
Laser Industries of Tel Aviv
Ear, Nose, Throat · 27d
Cleared Aug 16, 1982
MYRINGOTOMY KNIFE (VARIOUS TYPES)
K822162 · JYP
Kelleher Corp.
Ear, Nose, Throat · 24d
Cleared Aug 16, 1982
ENT CHISELS
K822165 · JYE
Kelleher Corp.
Ear, Nose, Throat · 24d