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
148057–148080 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 10, 1985
CYTO-TEK CENTRIFUGE
K852117 · IFB
Miles Laboratories, Inc.
Pathology · 26d
Cleared Jun 10, 1985
GLUCOSE(TRINDER) REAGENT
K852130 · CGA
Sigma Diagnostics, Inc.
Chemistry · 25d
Cleared Jun 10, 1985
BUN(ENDPOINT) REAGENT
K852131 · CDQ
Sigma Diagnostics, Inc.
Chemistry · 25d
Cleared Jun 10, 1985
SERUM IRON/VIBC REAGENT SET
K852161 · JIY
Livonia Diagnostics, Inc.
Toxicology · 21d
Cleared Jun 10, 1985
YSI MODEL 791/799 DISP TEMP PROBE & 7900 EX CABLE
K852246 · FLL
Yellow Springs Instrument Co., Inc.
General Hospital · 18d
Cleared Jun 07, 1985
VITAPEP
K844963 · BWF
Vitalograph , Ltd.
Anesthesiology · 165d
Cleared Jun 07, 1985
BIO-LOGIC PORTABLE EVOKED RESPONSE SYSTEM
K844992 · GWF
Bio-Logic Systems Corp.
Neurology · 163d
Cleared Jun 07, 1985
EMPTY SOLUTION TRANSFER CONTAINER
K850035 · KPE
The Healthcare Group Laboratories, Inc.
General Hospital · 151d
Cleared Jun 07, 1985
NATURAL MOTHER BREAST PUMP
K850753 · HGX
Crystal Medical Products, Inc.
Obstetrics & Gynecology · 102d
Cleared Jun 07, 1985
PASSY-MUIR TRACH VALVE
K851016 · BTO
Passy & Passy, Inc.
Anesthesiology · 87d
Cleared Jun 07, 1985
VASCULAR ACCESS CATHETER
K851195 · LJS
Sil-Med Corp.
General Hospital · 73d
Cleared Jun 07, 1985
WECK LX TM SKIN STAPLER
K851258 · GAG
Edward Weck, Inc.
General & Plastic Surgery · 71d
Cleared Jun 07, 1985
SURGICAL TOWELS
K851407 · JOJ
Diack
General Hospital · 59d
Cleared Jun 07, 1985
OHMEDA 5000 INFANT WARMER SYSTEM
K851449 · FMT
Ohmeda Medical
General Hospital · 57d
Cleared Jun 07, 1985
INFANT PHOTOTHERAPY MASK
K851918 · FOK
Alba Health Care
General Hospital · 36d
Cleared Jun 07, 1985
EDWARDS SACRAL SCREW
K851935 · KWP
Zimmer, Inc.
Orthopedic · 32d
Cleared Jun 07, 1985
INFUSION SETS MODELS 9120,9121,9125, 9122 & 9123
K852060 · FRN
Cardiac Pacemakers, Inc.
General Hospital · 29d
Cleared Jun 07, 1985
VIAL SYRINGE PUMPS, SE200, SE200B & SE400
K852073 · FRN
Hospal Medical Corp.
General Hospital · 25d
Cleared Jun 07, 1985
SPECTRUM(TENTATIVE)
K852078 · FOZ
Parke-Davis Co.
General Hospital · 25d
Cleared Jun 07, 1985
I.V. ADMINISTRATION SET
K852106 · FPA
Mediflex Intl.
General Hospital · 23d
Cleared Jun 07, 1985
KIMGUARD PROCEDURE TRAY
K852203 · FRG
Kimberly-Clark Corp.
General Hospital · 17d
Cleared Jun 07, 1985
STERILE EYE PACKS OR TRAYS
K852229
Surgeon Surgical Instrumentation, Inc.
Ophthalmic · 16d
Cleared Jun 07, 1985
STERETS INJECTION SWAB
K852235 · LKB
Ellis Pharmaceutical Consulting, Inc.
General Hospital · 16d
Cleared Jun 07, 1985
IVENT INTRAVENOUS ADMINSTRATION SET
K852259 · FPA
Ivent Corp.
General Hospital · 14d