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
137665–137688 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 06, 1987
TSA W/NEOMYCIN & 5% SHEEP BLOOD - # P3104 & Z3050
K874345 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 17d
Cleared Nov 06, 1987
HR(TM) NEEDLE AND SYRINGE
K874372 · FMI
Icu Medical, Inc.
General Hospital · 11d
Cleared Nov 06, 1987
HI-LO TEMP(R) SKIN TEMPERATURE SENSOR
K874404 · FLL
Mallinckrodt Critical Care
General Hospital · 9d
Cleared Nov 06, 1987
IV-PUSH, CONSTANT INFUSION PUMP
K874454 · KZD
Medical Products Search, Inc.
General Hospital · 9d
Cleared Nov 05, 1987
SKINLESS SKIN-HARMONY CONDOMS
K872664 · HIS
Okamoto USA, Inc.
Obstetrics & Gynecology · 120d
Cleared Nov 05, 1987
SKINLESS-SKIN, PINK TINT (CONDOM)
K872812 · HIS
Okamoto USA, Inc.
Obstetrics & Gynecology · 112d
Cleared Nov 05, 1987
FLEXIFLO COMPANION ENTERAL NUTRITION PUMP
K873119 · LZH
Frantz Medical Development, Ltd.
General Hospital · 87d
Cleared Nov 05, 1987
VALLEYLAB MODEL IV7200 INFUSION PUMP
K873161 · FRN
Valleylab, Inc.
General Hospital · 86d
Cleared Nov 05, 1987
WAKO(TM) AUTOKIT CK-NAC
K873201 · CGS
Wako Chemicals USA, Inc.
Chemistry · 84d
Cleared Nov 05, 1987
DALE I.V. CONNECT. LOCK & STABILIZER (STABILOK)220
K873311 · KMK
Dale Medical Products, Inc.
General Hospital · 80d
Cleared Nov 05, 1987
ELECTROMEDICS D1079E
K873561 · DTR
Electromedics, Inc.
Cardiovascular · 64d
Cleared Nov 05, 1987
PEDIATRIC BUBBLE TRAP CAT. NO. B-100
K873610 · BSY
American Omni Medical, Inc.
Anesthesiology · 58d
Cleared Nov 05, 1987
CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE
K873894 · FPA
Travenol Laboratories, S.A.
General Hospital · 42d
Cleared Nov 05, 1987
AMERLITE TT4 ASSAY (240/480/144 TEST KITS)
K873976 · KLI
Amersham Corp.
Chemistry · 37d
Cleared Nov 05, 1987
EMDS PROCAINAMIDE CALIBRATOR ITEM NO. 67634/95
K874102 · DLJ
Em Diagnostic Systems, Inc.
Toxicology · 28d
Cleared Nov 05, 1987
MEDTRONIC MODEL 6550 ADJUSTABLE HEMOSTASIS VALVE
K874117 · DYG
Medtronic Vascular
Cardiovascular · 27d
Cleared Nov 05, 1987
TITAN GEL REP CPK-12 HV
K874146 · CGS
Helena Laboratories
Chemistry · 23d
Cleared Nov 04, 1987
THE EXPERT MODELS RTS 2000 AND RTS 2000H
K862947 · DSI
Ocg Technology, Inc.
Cardiovascular · 456d
Cleared Nov 04, 1987
HENKE-JECT PRESSURE SYRINGE (MODIFICATION)
K864294 · EGM
Smith & Nephew, Inc.
Dental · 369d
Cleared Nov 04, 1987
PREVENTETTE (CONDOM)
K872619 · HIS
Reb Enterprises, Inc.
Obstetrics & Gynecology · 121d
Cleared Nov 04, 1987
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
K872766 · DXY
Telectronics, Inc.
Cardiovascular · 113d
Cleared Nov 04, 1987
PACESTART
K872778 · DRO
Pacific Rim Engineering & Mfg.
Cardiovascular · 113d
Cleared Nov 04, 1987
PROLOG MP PULSE GENERATORS 658K AND 658T
K872779 · DXY
Pacesetter Systems
Cardiovascular · 113d
Cleared Nov 04, 1987
MODEL 78576A PAPER CHART RECORDER
K872822 · DSF
Hewlett-Packard Co.
Cardiovascular · 110d