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
165865–165888 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 20, 1980
MAXI CAMERA 37
K801653 · IYX
General Electric Co.
Radiology · 33d
Cleared Aug 20, 1980
MAXI CAMERA 61
K801654 · IYX
General Electric Co.
Radiology · 33d
Cleared Aug 20, 1980
NON-INVASIVE, BLOOD PRESSURE MONITOR
K801657 · DXN
Biochem International, Inc.
Cardiovascular · 30d
Cleared Aug 20, 1980
SERALYZER GLUCOSE REAGENT STRIPS
K801663 · CGA
Miles Laboratories, Inc.
Chemistry · 30d
Cleared Aug 20, 1980
SERALYZER GLUCOSE TEST MODULE
K801664 · JQP
Miles Laboratories, Inc.
Chemistry · 30d
Cleared Aug 20, 1980
SERALYZER GLUCOSE CALIBRATORS(LOW&HIGH)
K801665 · JIS
Miles Laboratories, Inc.
Chemistry · 30d
Cleared Aug 20, 1980
FERRIZYME FERRITIN ENZYME IMMUNOASSAY
K801676 · DBF
Abbott Laboratories
Immunology · 29d
Cleared Aug 20, 1980
BK-1499 KAY-KPLINT HAND CONE/BK-1500
K801707 · ILH
Fred Sammons, Inc.
Physical Medicine · 27d
Cleared Aug 20, 1980
AMES TDA TM PHENYTOIN TEST
K801736 · LES
Miles Laboratories, Inc.
Toxicology · 26d
Cleared Aug 20, 1980
STERNUM SAW
K801737 · KFK
Amsco Co.
General & Plastic Surgery · 26d
Cleared Aug 20, 1980
VISTA 44 GAS CHROMATOGRAPHY ANALYSIS
K801745 · KZQ
Varian Assoc., Inc.
Chemistry · 23d
Cleared Aug 20, 1980
SUTURE REMOVAL PAK
K801746 · FZT
Devco Medical Industries, Inc.
General & Plastic Surgery · 23d
Cleared Aug 20, 1980
ADT BONE MARROW BIOPSY-ASPIR. NEELDE
K801753 · GAA
A.D.T. Lab Industries
General & Plastic Surgery · 23d
Cleared Aug 20, 1980
ADT BONE MARROW ASPIRATION NEEDLE
K801754 · GAA
A.D.T. Lab Industries
General & Plastic Surgery · 23d
Cleared Aug 20, 1980
MMI/GAELTEC CATHETER TIP TRANSDUC
K801756 · DXO
Medical Measurements, Inc.
Cardiovascular · 23d
Cleared Aug 20, 1980
EFFRON PAROTID RETRACTOR
K801759 · GAD
American V. Mueller
General & Plastic Surgery · 23d
Cleared Aug 20, 1980
PDS COMPUTER UNIT/VIDEO TERMINAL
K801761 · DRT
General Electric Co.
Cardiovascular · 23d
Cleared Aug 20, 1980
JACKSON-PRATT LARGE VOL. CLOSED WOUND
K801766 · GCY
American Heyer Schulte
General & Plastic Surgery · 23d
Cleared Aug 20, 1980
CONTAIN X-RAY DETECTABLE LAP SPONGE
K801768 · GDY
The Buckeye Cellulose Corp.
General & Plastic Surgery · 23d
Cleared Aug 20, 1980
MICROBIOLOGY CULTURE MEDIA-MACCONKEY AG
K801772 · JJH
Radiation Technology, Inc.
Microbiology · 23d
Cleared Aug 20, 1980
INTELECT
K801790 · IPF
Chattanooga Group, Inc.
Physical Medicine · 22d
Cleared Aug 20, 1980
SURGICAL INSTRUMENTS
K801819 · HXD
Robert I. Chien & Assoc., Inc.
General & Plastic Surgery · 20d
Cleared Aug 20, 1980
BAND-AID BRAND TRICOT MESH BANDAGES
K801823 · KGY
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 20d
Cleared Aug 20, 1980
BAND-AID BRAND FLEXIBLE FABRIC BANDAGE
K801824 · KGY
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 20d