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
166729–166752 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 29, 1980
PHADEBACT STREP D TEST
K800159 · GTZ
Pharmacia, Inc.
Microbiology · 96d
Cleared Apr 29, 1980
STERILE SPONGE BOWLS
K800440 · FNY
Premium Plastics, Inc.
General Hospital · 61d
Cleared Apr 29, 1980
3M TITANIUM ALLOY TOTAL HIP SYSTEM 32MM
K800487 · JDI
3M Company
Orthopedic · 56d
Cleared Apr 29, 1980
MX820-5 PRESSURE INFUSOR 500CC MX820-10
K800560 · KZD
Medex, Inc.
General Hospital · 48d
Cleared Apr 29, 1980
RADIOEAR MODEL RM-L & RM-C HEARING AID
K800567 · ESD
Radioear Corp.
Ear, Nose, Throat · 47d
Cleared Apr 29, 1980
EXTENSION LINE
K800622 · DQO
Norton Performance Plastics Corp.
Cardiovascular · 42d
Cleared Apr 29, 1980
AUTO-FIELD D AUTOMATED VISUAL DETECTOR
K800722 · HPT
Cavitron Corp.
Ophthalmic · 28d
Cleared Apr 29, 1980
BELTLESS MAXI, MINI & SUPER MAXI PADS
K800747 · HHD
Dafoe & Dafoe, Inc.
Obstetrics & Gynecology · 25d
Cleared Apr 29, 1980
NICKERSON'S MED. SELECTIVE CULTURE MEDIU
K800754 · JSJ
Ortho Pharmaceutical Corp.
Microbiology · 25d
Cleared Apr 29, 1980
DRAGER ORMC
K800764 · BZR
Draeger Medical, Inc.
Anesthesiology · 22d
Cleared Apr 29, 1980
DIGITAL ELECTRONIC B.P. MONITOR 2155
K800778 · DXN
Sears, Roebuck & Co.
Cardiovascular · 21d
Cleared Apr 29, 1980
MINUET MASKER
K800784 · KLW
Beltone Electronics Corp.
Ear, Nose, Throat · 21d
Cleared Apr 29, 1980
FAST HEMOGLOBIN CONTROL-LYOPHILIZED
K800794 · LCP
Isolab, Inc.
Chemistry · 20d
Cleared Apr 29, 1980
QUICK FILL
K800823 · DXT
Medrad, Inc.
Cardiovascular · 15d
Cleared Apr 29, 1980
PREMIER ABSORBENT POINTS
K800827 · EKN
Premier Dental Products Co.
Dental · 15d
Cleared Apr 29, 1980
MYERSON'S SPECIAL CROWN & BRIDGE RESIN
K800828 · EBG
Myerson Tooth Corp.
Dental · 15d
Cleared Apr 29, 1980
A,SA2 LYOPHILIZED HEMO CONTROL
K800853 · JBD
Helena Laboratories
Hematology · 14d
Cleared Apr 29, 1980
A,A2 LYOPHILIZED HEMO CONTROL
K800854 · JBD
Helena Laboratories
Hematology · 14d
Cleared Apr 29, 1980
A,FSC LYOPHILIZED HEMO CONTROL
K800855 · JBD
Helena Laboratories
Hematology · 14d
Cleared Apr 29, 1980
A,FDA2 LYOPHILIZED HEMO CONTROL
K800856 · JBD
Helena Laboratories
Hematology · 14d
Cleared Apr 29, 1980
OMNISTIK, MQ 501GS
K800860 · CBT
Marquest Medical Products, Inc.
Anesthesiology · 13d
Cleared Apr 29, 1980
FERRO-QUANT TM FE 59 TEST KIT
K800868 · JQG
Mallinckrodt Critical Care
Chemistry · 12d
Cleared Apr 29, 1980
ANTICONVULSANTS TOXICOLOGY CONTROL
K800882 · DIF
Utak Laboratories, Inc.
Toxicology · 12d
Cleared Apr 29, 1980
CARDIACS I TOXICOLOGY CONTROL
K800883 · DIF
Utak Laboratories, Inc.
Toxicology · 12d