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
172945–172968 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 02, 1977
MALE LUER LOCK PLUG
K771339 · FPA
American Viggo
General Hospital · 14d
Cleared Aug 02, 1977
ECONOWRAP PAPER C.S.R. WRAP
K771348 · FRG
Tower Products, Inc.
General Hospital · 12d
Cleared Aug 02, 1977
MODIFICATION TO KIDNEY DIALYZER
K771349 · FHS
Erika, Inc.
Gastroenterology & Urology · 12d
Cleared Aug 02, 1977
LUBE JEL
K771364 · FHX
Travenol Laboratories, S.A.
Gastroenterology & Urology · 8d
Cleared Aug 02, 1977
CHOLEDOCHOSCOPE SYSTEM
K771367 · FBN
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 8d
Cleared Jul 29, 1977
CATHETER THORACIC, AXIOM
K770983 · JOL
Axiom Medical, Inc.
General Hospital · 59d
Cleared Jul 29, 1977
NEEDLE, CHIBA UNIVERSITY
K771108 · FCG
Johannah Medical Services, Inc.
Gastroenterology & Urology · 39d
Cleared Jul 29, 1977
POST-AURICULAR HEARING AID HC 880
K771356 · ESD
Hc Electronics
Ear, Nose, Throat · 7d
Cleared Jul 29, 1977
GROUP AUDITORY TRAINER HC 431R
K771357 · EPF
Hc Electronics
Ear, Nose, Throat · 7d
Cleared Jul 27, 1977
INSTATEMP
K770944 · KDP
H.I. Silverman, D.Sc.
General Hospital · 63d
Cleared Jul 27, 1977
ENDOMETRIAL ASPIRATION BIOSPY KIT 182341
K771149 · HHK
C.R. Bard, Inc.
Obstetrics & Gynecology · 30d
Cleared Jul 27, 1977
GUSBERG HYSTERECTOMY CLAMP
K771344 · HGC
J. Sklar Mfg. Co., Inc.
Obstetrics & Gynecology · 14d
Cleared Jul 26, 1977
TERUFUSION BLOOD ADMIN. SET
K771209 · FMI
Terumo America, Inc.
General Hospital · 21d
Cleared Jul 25, 1977
SURGIPULSE HEART RATE MONITOR
K771199 · DRT
Stryker Corp.
Cardiovascular · 20d
Cleared Jul 21, 1977
MASK, VAPOR, MONOMER
K770690 · JDY
Howmedica Corp.
Orthopedic · 99d
Cleared Jul 21, 1977
TISSUE CULTURE MEDIA W/HEPES BUFFER
K770764 · KIT
Microbiological Assoc.
Microbiology · 85d
Cleared Jul 21, 1977
CHROMATOGRAPHY ANALYSIS SYS, MODEL 8500
K770827
Varian Assoc., Inc.
Chemistry · 77d
Cleared Jul 21, 1977
DATA REDUCTION SYSTEM, DP-3000
K770877 · JQP
Beckman Instruments, Inc.
Chemistry · 66d
Cleared Jul 21, 1977
FRACTURE CAST BRACE KIT, PLASTIC
K770898 · HSP
Chase Mfg. Co.
Orthopedic · 66d
Cleared Jul 21, 1977
FRACTURE CAST BRACE, POLY
K770899 · ITM
Chase Mfg. Co.
Physical Medicine · 66d
Cleared Jul 21, 1977
CAST BRWM, FRACTURE
K770900 · ITM
Chase Mfg. Co.
Physical Medicine · 66d
Cleared Jul 21, 1977
PHADECODE DIFFERENTIAL FACTOR XA1 ASSAY
K770942 · JBQ
Pharmaseal Div., Baxter Healthcare Corp.
Hematology · 58d
Cleared Jul 21, 1977
DIAG. OZYRATE GLUCOSE REAG. SET
K771059 · CGA
J.T. Baker Chemical Co.
Chemistry · 38d
Cleared Jul 21, 1977
DIAG. CONDUCTA RATE BUN REAG. SET
K771060 · CDS
J.T. Baker Chemical Co.
Chemistry · 38d