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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
117121–117144 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 22, 1992
APOLIPOPROTEIN TEST SYSTEM
K921037 · MSJ
Baxter Diagnostics, Inc.
Immunology · 79d
Cleared May 22, 1992
PHADEBACT MONOCLONAL GC TEST, MODIFICATION
K921075 · LIC
Karo Bio Diagnostics AB
Microbiology · 84d
Cleared May 22, 1992
MODELS 6917T, 6917AT & 4951M EPICARDIAL PACE LEADS
K921124 · DTB
Medtronic Vascular
Cardiovascular · 102d
Cleared May 22, 1992
PHILIPS 31 SERIES IN THE EAR HEARING AID
K921463 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 56d
Cleared May 22, 1992
ACTION FX MANUAL WHEELCHAIR
K921847 · IOR
Invacare Corp.
Physical Medicine · 35d
Cleared May 21, 1992
UNIMAX MODEL 2000 COLOR-CORRECTED MICROSPOT CO2
K920821 · GEX
Reliant Laser Corp.
General & Plastic Surgery · 87d
Cleared May 21, 1992
LIFESTREAM CENTRIFUGAL PUMP SYSTEM MODEL 2100CP
K921550 · KFM
St. Jude Medical, Inc.
Cardiovascular · 58d
Cleared May 20, 1992
AUTOLOGOUS BLOOD PROCESSING SYSTEM
K913181 · CAC
Lifestream Int'L, Inc.
Anesthesiology · 307d
Cleared May 20, 1992
EZ-1 SYSTEM RESPIRATORY EFFORT SENSORS
K913395 · BZG
Pro-Tech, Inc.
Anesthesiology · 295d
Cleared May 20, 1992
MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540-D
K914754 · DWA
Medtronic Bio-Medicus, Inc.
Cardiovascular · 211d
Cleared May 20, 1992
E-Z-FLOW ANGIOGRAPHY CATHETERS, MODIFICATION
K914984 · DQY
E-Z-Em, Inc.
Cardiovascular · 210d
Cleared May 20, 1992
GUIDE WIRES, MODIFICATION
K914986 · DQX
E-Z-Em, Inc.
Cardiovascular · 209d
Cleared May 20, 1992
HIGH PRESSURE CONNECTING SETS, MODIFICATION
K914987 · DTL
E-Z-Em, Inc.
Cardiovascular · 209d
Cleared May 20, 1992
MICROCHAMBER
K915211 · CAF
Respiratory Delivery Systems, Inc.
Anesthesiology · 184d
Cleared May 20, 1992
IOWA ORAL PERFORMANCE ISNTRUMENT
K920091 · IKE
Breakthrough, Inc.
Physical Medicine · 133d
Cleared May 20, 1992
MEDTRONIC RESPOND III NEUROMUSCULAR STIMULATOR
K920436 · IPF
Medtronic Vascular
Physical Medicine · 107d
Cleared May 20, 1992
MODELS 3987 AND 3988 RESUME LEAD FOR PNS
K920567 · GZF
Medtronic Vascular
Neurology · 103d
Cleared May 20, 1992
NOROTRACK 360 INCLINOMETER
K920690 · KQX
Noromed, Inc.
Neurology · 96d
Cleared May 19, 1992
AUSONICS OPUS 1 SYSTEM, ANNULAR ARRAY OPTION
K920307 · ITX
Ausonics Pty , Ltd.
Radiology · 117d
Cleared May 19, 1992
SPYROFLEX WOUND CLOSURES
K921775 · FPX
Polymint Industrial Co. , Ltd.
General & Plastic Surgery · 39d
Cleared May 18, 1992
SPORICIDIN BRAND DISINFECTANT TOWELETTES
K904579 · LRJ
Sporicidin Intl.
General Hospital · 587d
Cleared May 18, 1992
SPORICIDIN BRAND DISINFECTANT SPRAY
K904580 · LRJ
Sporicidin Intl.
General Hospital · 587d
Cleared May 18, 1992
SPORICIDIN BRAND DISINFECTANT SOLUTION
K904581 · LRJ
Sporicidin Intl.
General Hospital · 587d
Cleared May 18, 1992
SABRATEK 3030 INFUSION PUMP
K914589 · FRN
Sabratek Corp.
General Hospital · 215d