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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
73417–73440 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 01, 2002
PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS
K011005 · FIP
Pure Water Solutions, Inc.
Gastroenterology & Urology · 576d
Cleared Nov 01, 2002
REGENECARE WOUND GEL
K020540 · SEJ
Mpm Medical., Inc.
General & Plastic Surgery · 255d
Cleared Nov 01, 2002
PURTIAN BENNETT, GOOD KNIGHT 420G MODEL M-113900-US
K020886 · BZD
Tyco Healthcare Nancy
Anesthesiology · 228d
Cleared Nov 01, 2002
STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT
K021551 · MQV
Biocomposites, Ltd.
Orthopedic · 172d
Cleared Nov 01, 2002
SYNTHES LOW PROFILE NEURO SYSTEM
K022012 · JEY
Synthes (Usa)
Dental · 134d
Cleared Nov 01, 2002
VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT
K022021 · GFO
Vital Scientific N.V.
Hematology · 134d
Cleared Nov 01, 2002
THOMAS MEDICAL ELECTRODES
K022593 · HGI
Thomas Medical, Inc.
Obstetrics & Gynecology · 88d
Cleared Nov 01, 2002
PLAYTEX BREAST PUMP
K022594 · HGX
Playtex Products, Inc.
Obstetrics & Gynecology · 88d
Cleared Nov 01, 2002
K-FIX
K022597 · HTY
New Deal, S.A.
Orthopedic · 88d
Cleared Nov 01, 2002
AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST STRIP (DIPSTICK)
K022680 · DHA
Azog, Inc.
Chemistry · 81d
Cleared Nov 01, 2002
AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST (DEVICE OR CASSETTE)
K022681 · DHA
Azog, Inc.
Chemistry · 81d
Cleared Nov 01, 2002
STEPHENS DISPOSABLE FORCEPS
K022835 · HNR
Stephens Instruments
Ophthalmic · 66d
Cleared Nov 01, 2002
STEPHENS DISPOSABLE SPECULUM
K022836 · HNC
Stephens Instruments
Ophthalmic · 66d
Cleared Nov 01, 2002
STEPHENS DISPOSABLE SCISSORS
K022840 · HNF
Stephens Instruments
Ophthalmic · 66d
Cleared Nov 01, 2002
STEPHENS DISPOSABLE HOOKS
K022842 · HNQ
Stephens Instruments
Ophthalmic · 66d
Cleared Nov 01, 2002
GAYHEART CORNEAL EXCISION DEVICE
K022843 · HRH
Stephens Instruments
Ophthalmic · 66d
Cleared Nov 01, 2002
WIENER LAB. BILIRRUBINA TOTAL AA
K022962 · CIG
Wiener Laboratories Saic
Chemistry · 56d
Cleared Nov 01, 2002
LUCIUS 76
K023196 · EJT
Sb Lucius, Inc.
Dental · 37d
Cleared Nov 01, 2002
CERANUM 90
K023198 · EJT
Sb Lucius, Inc.
Dental · 37d
Cleared Nov 01, 2002
CONTROL PLASMA N
K023309 · GIZ
Dade Behring, Inc.
Hematology · 29d
Cleared Nov 01, 2002
CONTROL PLASMA P
K023312 · GGC
Dade Behring, Inc.
Hematology · 29d
Cleared Nov 01, 2002
ULTRASOUND SCANNER, TYPE 1101
K023457 · IYO
B & K Medical A/S
Radiology · 17d
Cleared Nov 01, 2002
TIMEX ACCUCURVE TALKING 30 SECOND THERMOMTER
K023538 · FLL
Medport, Inc.
General Hospital · 11d
Cleared Oct 31, 2002
SHERLOCK MYCOBACTERIA IDENTIFICATION SYSTEM
K020689 · NJO
Midi, Inc.
Microbiology · 241d