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
138169–138192 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 1987
SABOUR DEXTR W/CHLORAMPHEN/GENTAM SD W/C&G AGAR PL
K873318 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 42d
Cleared Sep 29, 1987
SABOURAUD DEXTROSE (SD) W/CHLORAMP AGAR PLATE
K873319 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 42d
Cleared Sep 29, 1987
SABOURAUD DEXTR/BHI SD/BHI AGAR SLT W/6% SHEEP BLD
K873320 · KZI
Lakewood Biochemical Co., Inc.
Microbiology · 42d
Cleared Sep 29, 1987
SABOUR DEXTROSE/BHI SD/BHI AGAR SLT TUBE #T4300
K873321 · KZI
Lakewood Biochemical Co., Inc.
Microbiology · 42d
Cleared Sep 29, 1987
SABOUR DEXTR SD AGAR SLNT TUBE W/CHLORAMP #T3088
K873322 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 42d
Cleared Sep 29, 1987
EASY-TEST EMIT PROCAINAMIDE (PROC) #16648
K873350 · LAR
Em Diagnostic Systems, Inc.
Toxicology · 40d
Cleared Sep 29, 1987
QBC VENOUS BLOOD CONTROL/MULTIPLE
K873354 · JPK
R&D Systems, Inc.
Hematology · 40d
Cleared Sep 29, 1987
QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL
K873467 · DIF
Quantimetrix Medical Industries
Chemistry · 32d
Cleared Sep 29, 1987
CUSTOM IN-THE-EAR HEARING AID SERIES MCA20
K873468 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 32d
Cleared Sep 29, 1987
UTERINE INJECTOR 2MM
K873515 · HES
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 29d
Cleared Sep 29, 1987
OPTI-ZYME(R)
K873548 · LPN
Alcon Laboratories
Ophthalmic · 29d
Cleared Sep 29, 1987
U-IMPULSE AIR CONDUCTION IN-THE-CANAL HEARING AID
K873560 · ESD
Richards Medical Co., Inc.
Ear, Nose, Throat · 27d
Cleared Sep 29, 1987
TIF FECAL TEST
K873594 · LEA
Devetec, Inc.
Pathology · 25d
Cleared Sep 29, 1987
MICRO-CHEM ANALYZER
K873638 · JJQ
Ocean Scientific, Inc.
Chemistry · 20d
Cleared Sep 29, 1987
SPECTROPHOTOMETER (MICROASSAY PLATE READERS)
K873678 · JJQ
Slt Labinstruments, Inc.
Chemistry · 15d
Cleared Sep 29, 1987
ALKALINE PHOSPHATASE (ALK P) TESTPACK #67690/95
K873681 · CJE
Em Diagnostic Systems, Inc.
Chemistry · 15d
Cleared Sep 28, 1987
UNIVERSAL JET VENTILATOR MODEL AMS-1000
K863155 · CBK
Acutronic Medical Systems AG
Anesthesiology · 409d
Cleared Sep 28, 1987
AUXILIARY CONTINUOUS WAVE DOPPLER TRANSDUCER
K871416 · JOP
Acuson Computed Sonography
Cardiovascular · 174d
Cleared Sep 28, 1987
ACUSON L538 TRANSDUCER
K871506 · JOP
Acuson Computed Sonography
Cardiovascular · 164d
Cleared Sep 28, 1987
H-H HUNTER ACTIVE TENDON IMPLANT PC
K872284 · HXA
Holter-Hausner Intl.
Orthopedic · 104d
Cleared Sep 28, 1987
H-H HUNTER ACTIVE TENDON IMPLANT DC
K872285 · HXA
Holter-Hausner Intl.
Orthopedic · 104d
Cleared Sep 28, 1987
H-H HUNTER ACTIVE TENDON IMPLANT BC
K872293 · HXA
Holter-Hausner Intl.
Orthopedic · 104d
Cleared Sep 28, 1987
MODEL 20-C W/AR-10A/U ATTACH. FOR ARTHRO. SURGERY
K872711 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 83d
Cleared Sep 28, 1987
SPERM-SELECT ADDITIONAL INDICATION
K872849 · HDR
Pharmacia, Inc.
Obstetrics & Gynecology · 70d