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
165793–165816 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 17, 1980
POSTOPERATIVE UV GLASSES (PLANO/APHAKIC)
K802651 · HQG
Chiron Vision Corp.
Ophthalmic · 54d
Cleared Dec 17, 1980
SILANIT
K802679 · EBG
Vivadent (Usa), Inc.
Dental · 50d
Cleared Dec 17, 1980
BLENDED BIFOCAL
K802749 · HQG
Robinson-Houchin, Inc.
Ophthalmic · 44d
Cleared Dec 17, 1980
POROPLAST-EYE DRESSING
K802786 · HOY
Secol Co.
Ophthalmic · 43d
Cleared Dec 17, 1980
METALLINE DRESSINGS
K802787 · KKX
Secol Co.
General Hospital · 43d
Cleared Dec 17, 1980
ZINC PASTE BANDAGE
K802791 · FRO
Secol Co.
General & Plastic Surgery · 43d
Cleared Dec 17, 1980
O.R. DRAPES
K802797 · KKX
Secol Co.
General Hospital · 43d
Cleared Dec 17, 1980
EYE PADS
K802799 · HMP
Secol Co.
General & Plastic Surgery · 43d
Cleared Dec 17, 1980
PMR-2 PURITAN MANUAL RESUSCITATOR
K802813 · BTM
Puritan Bennett Corp.
Anesthesiology · 40d
Cleared Dec 17, 1980
CONCEPT CANALICULUS INTUBATION SET
K802845 · HNL
Concept, Inc.
Ophthalmic · 35d
Cleared Dec 17, 1980
TCM202 TCPO2 & TCM204 TCPO2/PO2 REC. SY.
K802846 · KLK
The London Co.
Anesthesiology · 35d
Cleared Dec 17, 1980
RION ELECTRO-PALATOGRAPH MODEL DP-01
K802870 · LEZ
Kindel & Anderson
Ear, Nose, Throat · 33d
Cleared Dec 17, 1980
EXTRACORPOREAL'S #DM-952 DIALYSATE BYPAS
K802880 · FKP
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 30d
Cleared Dec 17, 1980
TRAVENOL INFUSION PUMP-2M8016
K802901 · FRN
Travenol Laboratories, S.A.
General Hospital · 30d
Cleared Dec 17, 1980
ULNAR FRACTURE BRACE
K802908 · IQI
Orthomedics
Physical Medicine · 30d
Cleared Dec 17, 1980
HUMERAL FRACTURE BRACE
K802909 · IQI
Orthomedics
Physical Medicine · 30d
Cleared Dec 17, 1980
A/K SOCKET
K802911 · ISS
Orthomedics
Physical Medicine · 30d
Cleared Dec 17, 1980
POROUS COATED ANATOMICAL-TOTAL KNEE
K802922 · JWH
Howmedica Corp.
Orthopedic · 29d
Cleared Dec 17, 1980
SPIROMETRIC COMPUTER #SC-10
K802928 · BZC
Cavitron Corp.
Anesthesiology · 28d
Cleared Dec 17, 1980
I.M PROBES
K802951 · HXB
Hogan & Hartson
Orthopedic · 27d
Cleared Dec 17, 1980
DRESSING CHANGE TRAY-MEDIUM
K802954 · FKO
Associated Medical Products Co.
Gastroenterology & Urology · 27d
Cleared Dec 17, 1980
LEMON GLYCERINE SWABS
K803201
Walpak Co.
General Hospital
Cleared Dec 16, 1980
UNIFOCAL VP, MODELS 7501 AND 7502
K800746 · DXY
American Pacemaker Corp.
Cardiovascular · 257d
Cleared Dec 16, 1980
LARES HANDPIECE OIL
K801535 · EFB
Lares Manufacturing Co., Inc.
Dental · 166d