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
142033–142056 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 17, 1986
IMPROVED COMSPAN
K863552 · EBF
Dentsply Intl.
Dental · 35d
Cleared Oct 17, 1986
ACTIN FSL ACTIVATED PTT REAGENT
K863594 · GGW
American Dade
Hematology · 32d
Cleared Oct 17, 1986
ROTARY* POWERED SCALPEL
K863731 · GEI
Self Sharpening Surgical Steel, Inc.
General & Plastic Surgery · 24d
Cleared Oct 17, 1986
FOUNDATIONS PLUS FACIAL-CHIN-NECK SUPPORTER 1000
K863754
Foundations Plus, Inc.
General & Plastic Surgery · 22d
Cleared Oct 16, 1986
BAUSCH & LOMB CLEANING PAD
K843511 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 770d
Cleared Oct 16, 1986
KONTRON VITALMON 5010 PATIENT MONITOR
K852249 · BZQ
Kontron Instruments, Inc.
Anesthesiology · 511d
Cleared Oct 16, 1986
PATIENT MON 1280/1281/120C/121C & MULTI-PARA CART
K860646 · DPS
Analogic Corp.
Cardiovascular · 238d
Cleared Oct 16, 1986
MODEL 545-45 FOR NEUROLOGICAL SURGICAL APPLICATION
K860977 · LLF
Britt Corp., Inc.
Neurology · 216d
Cleared Oct 16, 1986
HS-15M MICROWAVE SURGERY EQUIPMENT, MICROTAZE
K861904 · KNS
Cooper Lasersonics, Inc.
Gastroenterology & Urology · 153d
Cleared Oct 16, 1986
HEPACRON PUREAIR-ZONE SYSTEM
K862432 · FRF
Hepacron, Inc.
General Hospital · 112d
Cleared Oct 16, 1986
BARD IRYFIX(TM) STOMA CAP
K862631 · EXB
C.R. Bard, Inc.
Gastroenterology & Urology · 98d
Cleared Oct 16, 1986
COMMVIEW SYSTEM
K862715 · LMD
A T & T Technologies, Inc.
Radiology · 91d
Cleared Oct 16, 1986
HYDRO-CLENZ UNIT
K863539 · KPL
Atlantic Health Group
Gastroenterology & Urology · 35d
Cleared Oct 16, 1986
GSC 1000
K863566 · JJQ
Genetic Systems Corp.
Chemistry · 34d
Cleared Oct 16, 1986
CHLORIDE PROCEDURE
K863585 · CHJ
Data Medical Associates, Inc.
Chemistry · 31d
Cleared Oct 16, 1986
SODIUM BICARBONATE POWDER/BICARBONATE HEMODIALYSIS
K863631 · KPO
American Healthcare Corp.
Gastroenterology & Urology · 29d
Cleared Oct 16, 1986
SAFETY PINS, ELASTIC BANDAGES & STOCKINETTES
K863633 · LDQ
Biological & Environmental Control...
General & Plastic Surgery · 29d
Cleared Oct 16, 1986
FOLLICLE STIMULATING HORMONE IMMUNOASSAY SYSTEM
K863678 · CGJ
Nichols Institute Diagnostics
Chemistry · 27d
Cleared Oct 16, 1986
ALLEGRO LUTEINIZING HORMONE IMMUNOASSAY SYSTEM
K863679 · CEP
Nichols Institute Diagnostics
Chemistry · 27d
Cleared Oct 16, 1986
CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEM
K863830 · EZQ
Coloplast A/S
Gastroenterology & Urology · 16d
Cleared Oct 16, 1986
ACID PHOSPHATASE (ACP) REAGENT
K863851 · CKB
Sigma Diagnostics, Inc.
Chemistry · 14d
Cleared Oct 15, 1986
COMFORTRON
K862092 · KZM
M. D. Supply, Inc.
Dental · 135d
Cleared Oct 15, 1986
EXACTECH TOTAL HIP SYSTEM
K862234 · JDI
Exactech, Inc.
Orthopedic · 126d
Cleared Oct 15, 1986
BIVONA FOME-CUF LASER ENDOTRACHEAL TUBE
K862238 · BTR
Bivona Medical Technologies
Anesthesiology · 125d