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
165265–165288 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 12, 1980
KNEE BRACE/STABILIZER
K802673 · ITQ
Omni Scientific, Inc.
Physical Medicine · 16d
Cleared Nov 12, 1980
ORHTOPEDIC REAMER 87 HTD
K802676 · HTD
Zimmer, Inc.
General & Plastic Surgery · 14d
Cleared Nov 12, 1980
CLOSED-END/OPEN-END COLOSTOMY PCH. W/CON
K802677 · EXB
Johnson & Johnson Professionals, Inc.
Gastroenterology & Urology · 14d
Cleared Nov 12, 1980
ISOPAST-DS
K802680 · EBF
Vivadent (Usa), Inc.
Dental · 15d
Cleared Nov 12, 1980
REOLIT
K802685 · EJK
Vivadent (Usa), Inc.
Dental · 15d
Cleared Nov 12, 1980
JACOB CHUCK
K802694 · LXH
Richard Wolf Medical Instruments Corp.
Orthopedic · 13d
Cleared Nov 12, 1980
DENTAL MOUTH PROP.
K802696 · JXL
Trident Dental, Inc.
Neurology · 13d
Cleared Nov 12, 1980
LIQUID CHROMATOGRAPHY COLUMNS
K802703 · DPM
Supelco, Inc.
Toxicology · 12d
Cleared Nov 12, 1980
DRAGER PEEP CONTROL SYSTEM
K802707 · BYE
Draeger Medical, Inc.
Anesthesiology · 12d
Cleared Nov 12, 1980
INFANT APNEA MONITOR
K802710 · FLS
Douglas Scientific Products
Anesthesiology · 12d
Cleared Nov 12, 1980
DEN-MAT FIBER OPTIC HALOGEN LIGHT
K802716 · EAY
Den-Mat Corp.
Dental · 12d
Cleared Nov 12, 1980
P-10 POSTERIOR FILLING MATERIAL
K802751 · EBH
3M Company
Dental · 9d
Cleared Nov 10, 1980
MODEL SD-1 DISINTEGRATOR
K802322 · FFK
Northgate Research, Inc.
Gastroenterology & Urology · 48d
Cleared Nov 05, 1980
NEMECTRODYN 5
K802805
Nemectron Medical, Inc.
Physical Medicine
Cleared Oct 31, 1980
COMPUPACE, 524-01 PACER SYSTEM COMPUTER
K801055 · DTE
Intermedics, Inc.
Cardiovascular · 178d
Cleared Oct 31, 1980
GAMBRO HEMOFREEZE-BAG
K801082 · KSR
Gambro, Inc.
Hematology · 177d
Cleared Oct 31, 1980
PLASMAPOOLER
K801219 · KSR
North American Biologicals, Inc.
Hematology · 163d
Cleared Oct 31, 1980
CELLTRIFUGE II
K801233 · GKT
Travenol Laboratories, S.A.
Hematology · 157d
Cleared Oct 31, 1980
PACEPATH MODEL 810
K801416 · DTB
Pacesetter Systems
Cardiovascular · 137d
Cleared Oct 31, 1980
THERMOCOMP
K801553 · IYM
Hospital Financial Corp.
Radiology · 115d
Cleared Oct 31, 1980
HOLLO FIBER DIALYZER
K801559 · FJI
Renal Devices, Inc.
Gastroenterology & Urology · 115d
Cleared Oct 31, 1980
DEPALMA ELBOW
K801574 · JDB
Zimmer, Inc.
Orthopedic · 114d
Cleared Oct 31, 1980
ANDROSTENEDIONE RADIOIMMUNOASSAY KIT
K801729 · CIZ
Diagnostics Biochem Canada, Inc.
Chemistry · 99d
Cleared Oct 31, 1980
FERTILITY AWARENESS METHOD KIT
K801791 · FLK
Telesis Corp.
General Hospital · 94d