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
117697–117720 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 19, 1992
MODEL AR-6300 INFUSION PUMP
K915721 · HRX
Arthrex, Inc.
Orthopedic · 90d
Cleared Mar 19, 1992
AQUEOUS PARACENTESIS PIPET
K915808 · KYG
Visitec Co.
Ophthalmic · 86d
Cleared Mar 19, 1992
ACCUSCREEN ASSAY
K920018 · DKZ
Jk Research
Toxicology · 77d
Cleared Mar 19, 1992
S-ROM LF FEMORAL HEAD
K920317 · JDI
Joint Medical Products Corp.
Orthopedic · 55d
Cleared Mar 19, 1992
TOOTH BONDING AGENT
K920365 · EBF
Voco GmbH
Dental · 51d
Cleared Mar 19, 1992
ABBOTT VERTEX ANALYZER
K920559 · JJJ
Abbott Laboratories
Chemistry · 41d
Cleared Mar 19, 1992
GDC-3338, DENTAL SOLDER ALLOY
K920887 · EJS
Deringer-Ney, Inc.
Dental · 77d
Cleared Mar 19, 1992
MICROLITE MICROTITER PLATE LUMINOMETER ML2200
K920888 · KHO
Dynatech Laboratories, Inc.
Chemistry · 37d
Cleared Mar 19, 1992
RIONET HEARING AID - HB 52DU
K920897 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 22d
Cleared Mar 19, 1992
BELTONE OPRA CLEAR VOICE-K HEARING AID
K921023 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 16d
Cleared Mar 18, 1992
VIRATEST-DIA(TM) MEASLES (RUBEOLA)
K910290 · LJB
Virus Reference Laboratory, Inc.
Microbiology · 421d
Cleared Mar 18, 1992
DAVIS LEAD APRON - VARIOUS CATALOGUE NUMBERS
K912326 · KPY
Davis Lead Aprons, Inc.
Radiology · 299d
Cleared Mar 18, 1992
DAVIS LEAD APRON GONADAL SHIELD-VARIOUS CAT. NOS.
K912327 · KPY
Davis Lead Aprons, Inc.
Radiology · 299d
Cleared Mar 18, 1992
DAVIS LEAD APRON/RADIOGRAPHIC VARIOUS CAT. NUMBERS
K912378 · KPY
Davis Lead Aprons, Inc.
Radiology · 294d
Cleared Mar 18, 1992
AMS SPHINCTER 800 URINARY PROSTHESIS
K912934 · FAG
American Medical Systems, Inc.
Gastroenterology & Urology · 257d
Cleared Mar 18, 1992
AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS
K912935 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 257d
Cleared Mar 18, 1992
TRANSFER-AID(TM)
K913985 · LHI
Healthtek, Inc.
General Hospital · 195d
Cleared Mar 18, 1992
MEDSURG LAPAROSCOPY TRAY
K914036 · LRO
Medsurg Industries, Inc.
General & Plastic Surgery · 190d
Cleared Mar 18, 1992
FRENTA II+ ENTERAL FEEDING PUMP
K914216 · LZH
Fresenius Pharma
General Hospital · 181d
Cleared Mar 18, 1992
IV START KIT
K914475 · LRS
Cypress Medical Products, Ltd.
General & Plastic Surgery · 162d
Cleared Mar 18, 1992
RIATRAC PLUS
K914958 · JJY
Becton Dickinson Advanced Diagnostics
Chemistry · 134d
Cleared Mar 18, 1992
ENCORE
K915113 · JJQ
Heraeus Kulzer, Inc.
Chemistry · 126d
Cleared Mar 18, 1992
ACCENT DG BALLOON URTERAL DILATOR SET, 10CM
K915392 · EZN
Cook Urological, Inc.
Gastroenterology & Urology · 110d
Cleared Mar 18, 1992
SUNGLASSES/READING GLASSES
K915605 · HQY
Royal Shine Enterprises, Ltd.
Ophthalmic · 93d