FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
164953–164976 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 16, 1980
PUIG MASSANA-SHILEY ANNULOPLASTY RING
K801879 · KRH
Shiley, Inc.
Cardiovascular · 132d
Cleared Dec 16, 1980
HP MODEL 77020A ULTRASOUND SYSTEM
K801954 · IYO
Hewlett-Packard Co.
Radiology · 120d
Cleared Dec 16, 1980
SONIC EAR
K802382 · ESD
Acousticon Electronics
Ear, Nose, Throat · 76d
Cleared Dec 16, 1980
MS 16 SYRINGE DRIVER
K802400 · FRN
Princeton Medical Instruments, Inc.
General Hospital · 75d
Cleared Dec 16, 1980
BLOOD PRESSURE UNIT MODEL 310
K802411 · DXN
Js & A Group
Cardiovascular · 74d
Cleared Dec 16, 1980
BLOOD PRESSURE UNIT MODEL 410
K802412 · DXN
Js & A Group
Cardiovascular · 74d