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
143257–143280 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 08, 1986
T.P.N. DRESSING CHANGE TRAY
K862219
Welmed Systems, Inc.
General & Plastic Surgery · 27d
Cleared Jul 08, 1986
WARSAW ORTHOPEDIC BONE PLATE
K862254 · HRS
Warsaw Orthopedic, Inc.
Orthopedic · 25d
Cleared Jul 08, 1986
KOTEX LIGHTDAYS DEODORANT PANTILINERS
K862285 · HHL
Kimberly-Clark Corp.
Obstetrics & Gynecology · 22d
Cleared Jul 08, 1986
(MT-27) THERMOMETER AND (M-10PC) PROBE COVERS
K862333 · FLL
Sharp Electronics Corp.
General Hospital · 19d
Cleared Jul 08, 1986
CATALOG NO. I/A 100 AND KPE 200
K862334
Ipax, Inc.
General & Plastic Surgery · 28d
Cleared Jul 08, 1986
PRO-CLEAN
K862367
Dermacare Products, Inc.
General & Plastic Surgery · 14d
Cleared Jul 07, 1986
5.0 MHZ INTRAOPERATIVE ARRAY
K860123 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 174d
Cleared Jul 07, 1986
MODEL 545-45 LASER FOR DERMA., POD., SURGICAL
K860974 · GEX
Britt Corp., Inc.
General & Plastic Surgery · 115d
Cleared Jul 07, 1986
DIRECT ACU-SLIDE TEST
K861212 · JHJ
Cal-Tech Diagnostics, Inc.
Chemistry · 98d
Cleared Jul 07, 1986
ULTRAMED TF 122 ULTRASON VASCU IMAG & DOPPLER SYST
K861378 · JOP
Ultramed, Inc.
Cardiovascular · 84d
Cleared Jul 07, 1986
MODIFIED FETAL MONITOR MODEL FM-2
K861556 · HGM
Advantage Medical Systems, Inc.
Obstetrics & Gynecology · 73d
Cleared Jul 07, 1986
TDX REA LACTIC ACID
K861741 · KHP
Abbott Laboratories
Chemistry · 62d
Cleared Jul 07, 1986
V-TREND QC URINE CHEMISTRY CONTROLS LEVEL, I & II
K861756 · JJW
Texas Immunology, Inc.
Chemistry · 62d
Cleared Jul 07, 1986
ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM
K861773 · DGB
Zygotek Systems, Inc.
Immunology · 61d
Cleared Jul 07, 1986
VANILMANDELIC ACID (VMA) REAGENT SET
K861962 · CDF
Sterling Diagnostics, Inc.
Chemistry · 48d
Cleared Jul 07, 1986
CIRCUIT ANES. BREATHING & COMPONENTS
K862003 · CAI
Vital Signs, Inc.
Anesthesiology · 41d
Cleared Jul 07, 1986
MODIFIED COTROPIN RADIOIMMUNOASSAY KIT
K862180 · CEP
Clinetics Corp.
Chemistry · 28d
Cleared Jul 07, 1986
RESUSCITATOR MODELS 10400/10500/10600/10700/10800
K862192 · BTL
U.O. Equipment Co.
Anesthesiology · 28d
Cleared Jul 07, 1986
LAURIER OVERNIGHT SANITARY NAPKIN (MODIFICATION)
K862270 · HHD
Kao Corp.
Obstetrics & Gynecology · 24d
Cleared Jul 07, 1986
LAURIER SAFETY LONG SANITARY NAPKIN (MODIFICATION)
K862271 · HHD
Kao Corp.
Obstetrics & Gynecology · 24d
Cleared Jul 07, 1986
THE D & C PAD-SAC
K862297 · HCY
Nu-Gyn-Tek, Inc.
Obstetrics & Gynecology · 20d
Cleared Jul 07, 1986
EASY-TEST (TM) EMIT* PHENOBARBITAL (PHNO)/67534/93
K862308 · DLZ
Em Diagnostic Systems, Inc.
Toxicology · 20d
Cleared Jul 07, 1986
HBDH (OPTIMIZED) REAGENT
K862319 · JMK
Sigma Chemical Co.
Chemistry · 19d
Cleared Jul 07, 1986
CHLAMYDIA KIT, STD KIT
K862322 · HHT
Intl. Cytobrush, Inc.
Obstetrics & Gynecology · 18d