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
138097–138120 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 05, 1987
LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET
K873435 · KOD
Level 1 Technologies, Inc.
Gastroenterology & Urology · 40d
Cleared Oct 05, 1987
KAWASUMI BLOOD TUBING LINE
K873516 · FJK
Kawasumi Laboratories Co., Ltd.
Gastroenterology & Urology · 35d
Cleared Oct 05, 1987
FLEX GOLD
K873649 · EJF
Flexmedics
Dental · 26d
Cleared Oct 05, 1987
CARERITE FACE MASK
K873705 · FXX
Cost Rite Health Products, Inc.
General Hospital · 21d
Cleared Oct 05, 1987
EAR AND EYE SPONGES
K873831 · EFQ
Ormed Mfg., Inc.
General & Plastic Surgery · 14d
Cleared Oct 02, 1987
ANSWER OVULATION TEST KIT
K871241 · CEP
Armkel, LLC
Chemistry · 189d
Cleared Oct 02, 1987
LEUCOPREP BRAND TUBE
K872775 · JCF
Bd Becton Dickinson Vacutainer...
Hematology · 80d
Cleared Oct 02, 1987
CON-DOA (TM) DRUGS OF ABUSE URINE CONTROL
K873037 · DIF
Diagnostic Products Corp.
Toxicology · 59d
Cleared Oct 02, 1987
BINAX L.S. TSH IRMA TEST KIT
K873303 · JLW
Binax, Inc.
Chemistry · 45d
Cleared Oct 02, 1987
SABOURAUD DEXTROSE SD AGAR SLT TUBE W/C&C #T4412
K873323 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 45d
Cleared Oct 02, 1987
SABOURAUD DEXTROSE (SD) BROTH TUBE, #T3331
K873324 · JSD
Lakewood Biochemical Co., Inc.
Microbiology · 45d
Cleared Oct 02, 1987
SABOURAUD DEXTROSE SD EMMONS MOD. AGAR SLT TUBE
K873325 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 45d
Cleared Oct 02, 1987
SABOURAUD DEXTROSE (SD) AGAR SLANT TUBE #T3080
K873326 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 45d
Cleared Oct 02, 1987
SABOURAUD DEXTROSE (SD) AGAR, PRODUCT #P3330
K873327 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 45d
Cleared Oct 02, 1987
SABOURAUD DEXTROSE - EMMONS AGAR PLATE #P3252
K873328 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 45d
Cleared Oct 02, 1987
HEKTOEN ENTERIC (HE) AGAR PRODUCT #P3330
K873329 · JSI
Lakewood Biochemical Co., Inc.
Microbiology · 43d
Cleared Oct 02, 1987
WAKO(TM) AUTOKIT ALP
K873333 · CJE
Wako Chemicals USA, Inc.
Chemistry · 44d
Cleared Oct 02, 1987
WAKO(TM) AUTOKIT CALCIUM
K873334 · CIC
Wako Chemicals USA, Inc.
Chemistry · 44d
Cleared Oct 02, 1987
WAKO(TM) AUTOKIT UREA N
K873335 · CDQ
Wako Chemicals USA, Inc.
Chemistry · 44d
Cleared Oct 02, 1987
CREATININE REAGENT
K873365 · CGX
Sigma Diagnostics, Inc.
Chemistry · 42d
Cleared Oct 02, 1987
ACA URINE BENZODIAZEPINES (UBENZ) SCREEN METHOD
K873538 · JXM
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 31d
Cleared Oct 02, 1987
TITAN GEL HDL CHOLESTEROL KIT
K873547 · LBT
Helena Laboratories
Chemistry · 31d
Cleared Oct 02, 1987
CONJUGATED BILIRUBIN (CBIL) ITEM NO. 67684/95
K873551 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 32d
Cleared Oct 02, 1987
ACA DU PONT URINE AMPHETAMINES (U AMP) SCREEN METH
K873622 · DKZ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 24d