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
166585–166608 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 20, 1980
STERILE DRAPE 17X18 W/3 FENESTRATION
K801033 · KKX
Veratex Corp.
General Hospital · 19d
Cleared May 20, 1980
PLY LESIVE
K801047 · LBH
May-Pell Chemical Development Co.
Dental · 15d
Cleared May 20, 1980
STERILE ABDOMINAL PAD
K801068 · KKX
Medspec Corp.
General Hospital · 14d
Cleared May 20, 1980
STERILE ISOLATION GOWN
K801069 · FYC
Medspec Corp.
General Hospital · 14d
Cleared May 20, 1980
STRAITH CHIN IMPLANTS
K801073 · FWP
Surgical Technology Laboratories, Inc.
General & Plastic Surgery · 14d
Cleared May 20, 1980
STRAITH CHISEL FORCEPS
K801075 · GEN
Surgical Technology Laboratories, Inc.
General & Plastic Surgery · 14d
Cleared May 20, 1980
KWIX-BITE X-RAY FILM HOLDER
K801079 · EGZ
Henry Schein, Inc.
Dental · 13d
Cleared May 20, 1980
EDWARDS ROD SLEEVES
K801080 · KWP
Zimmer, Inc.
Orthopedic · 13d
Cleared May 20, 1980
PRISMA-FILL
K801092 · EBF
Dentsply Intl.
Dental · 12d
Cleared May 20, 1980
PRISMA-BOND
K801093 · KLE
Dentsply Intl.
Dental · 12d
Cleared May 20, 1980
SARNS 7000 MONITOR MODULE
K801097 · DTQ
3M Health Care, Sarns
Cardiovascular · 11d
Cleared May 20, 1980
PRESSURE MONITOR, MODEL 1131B
K801110 · DSK
American Optical Corp.
Cardiovascular · 8d
Cleared May 20, 1980
DUNN ANTERIOR DISTRACTION SYSTEM
K801120 · KWP
Zimmer, Inc.
Orthopedic · 8d
Cleared May 20, 1980
BOUNDARY EXTREMITY DRAPE
K801132 · KKX
Procter & Gamble Mfg. Co.
General Hospital · 8d
Cleared May 20, 1980
DISPOSABLE SKIN RETRACTOR
K801151 · GZT
Cimarron Instruments, Inc.
Neurology · 7d
Cleared May 20, 1980
VALLEYLAB RETURN ELECTRODE MONITOR
K801153 · GEI
Valleylab, Inc.
General & Plastic Surgery · 6d
Cleared May 14, 1980
SMEC BALLOON CANNULA
K790755 · DSP
Smec, Inc.
Cardiovascular · 393d
Cleared May 14, 1980
CLEAR-VIEW MIRROR WARMER
K800382 · GET
Surgical Mechanical Research, Inc.
General & Plastic Surgery · 82d
Cleared May 14, 1980
INTRAVENOUS INFUSION PUMP, CODE 2M8015
K800629 · FRN
Travenol Laboratories, S.A.
General Hospital · 55d
Cleared May 14, 1980
ORBITOR
K800639 · JAA
Philips Medical Systems (Cleveland),...
Radiology · 51d
Cleared May 14, 1980
MODEL E03 ECHO-OPTHALMOSCOPE
K800652 · IYO
Kt Medical, Inc.
Radiology · 51d
Cleared May 14, 1980
FERRITIRON KIT CAT. #RP-1100
K800710 · JQG
Ria Products, Inc.
Immunology · 44d
Cleared May 14, 1980
MICRO-COIL 100 COIL DIALYZER
K800723 · FHS
Erika, Inc.
Gastroenterology & Urology · 43d
Cleared May 14, 1980
ELEV. BACK SUPPORT W/ADJ. ARM POSITIONER
K800759 · IYE
Radiation Products Design, Inc.
Radiology · 40d