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
136393–136416 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 02, 1988
MIC (SPECIFIC LINE) INSERTION KIT
K875126 · KNT
Medical Innovations Corp.
Gastroenterology & Urology · 78d
Cleared Mar 02, 1988
LAPAROFLATOR 3000, STANDARD AND ELECTRONIC
K875137 · HES
F.M. Wiest USA, Inc.
Obstetrics & Gynecology · 78d
Cleared Mar 02, 1988
PHARMASEAL STERILE UMBILICAL CORD CLAMP
K875166 · HWI
Baxter Healthcare Corp
Orthopedic · 76d
Cleared Mar 02, 1988
LUER LOCK CONNECTORS / RIDIG P.V.C.
K875188 · LFJ
Vas-Cath of Canada , Ltd.
Gastroenterology & Urology · 76d
Cleared Mar 02, 1988
TAMPAX COMPAK, COMPACT PLASTIC APPLI. SUPER TAMPON
K880022 · HIL
Tambrands, Inc.
Obstetrics & Gynecology · 57d
Cleared Mar 02, 1988
TAMPAX COMPAK, COMPACT PLASTIC APPLI. REGU. TAMPON
K880023 · HIL
Tambrands, Inc.
Obstetrics & Gynecology · 57d
Cleared Mar 02, 1988
CLOSED URINARY DRAINAGE BAG W/ANTI-REFLUX & PORT
K880034 · KNX
Lin-Mark, Inc.
Gastroenterology & Urology · 57d
Cleared Mar 02, 1988
BERGER PROSTATE CULTURE CYTOLOGY BRUSH
K880095 · FDX
Van-Tec, Inc.
Gastroenterology & Urology · 50d
Cleared Mar 02, 1988
VAN-TEC ASPIRATION BIOPSY SYSTEM W/COLLECTION CUP
K880096 · KNW
Van-Tec, Inc.
Gastroenterology & Urology · 50d
Cleared Mar 02, 1988
VAN-TEC AUTO BIOPSY NEEDLE
K880098 · KNW
Van-Tec, Inc.
Gastroenterology & Urology · 50d
Cleared Mar 02, 1988
VAN-TEC BLADDER EVACUATOR
K880099 · KQT
Van-Tec, Inc.
Gastroenterology & Urology · 50d
Cleared Mar 02, 1988
CODMAN SURGICAL PATTIE
K880402 · HBA
Codman & Shurtleff, Inc.
Neurology · 33d
Cleared Mar 02, 1988
DISPOSABLE DENTAL PROBE/EXPLORER
K880590 · EKJ
Baxter Healthcare Corp
Dental · 20d
Cleared Mar 01, 1988
KONTRON STRESSDATA STRESS DATA MANAGEMENT SYSTEM
K870816 · DSI
Kontron Instruments, Inc.
Cardiovascular · 364d
Cleared Mar 01, 1988
COMBISON(R) 310A REAL TIME ULTRASOUND SCANNER
K873159 · IYO
Cone Instruments, Inc.
Radiology · 203d
Cleared Mar 01, 1988
GEN-PROBE PACE SYSTEM FOR NEISSERIA GONORRHOEAE
K874620 · LSL
Gen-Probe, Inc.
Microbiology · 113d
Cleared Mar 01, 1988
ADAP-TEMP, MODEL: AT-100
K874694 · FLL
Respiratory Support Products, Inc.
General Hospital · 109d
Cleared Mar 01, 1988
VIROGEN CMV ANTIBODY TEST
K875101 · LQO
Wampole Laboratories
Microbiology · 82d
Cleared Mar 01, 1988
(SKD) CHOLESTEROL TEST KIT
K875131 · CHH
Smithkline Diagnostics, Inc.
Chemistry · 77d
Cleared Mar 01, 1988
CAVIT-W
K875133 · EBG
Espe GmbH (Us)
Dental · 77d
Cleared Mar 01, 1988
REVISED LABELING FOR ADX BARBITURATES
K880012 · DIS
Abbott Laboratories
Toxicology · 57d
Cleared Mar 01, 1988
REVISED LABELING FOR ADX AMPHETAMINE/METHAMPHETA.
K880013 · DKZ
Abbott Laboratories
Toxicology · 57d
Cleared Mar 01, 1988
REVISED LABELING FOR ADX CANNABINOIDS
K880015 · LDJ
Abbott Laboratories
Toxicology · 57d
Cleared Mar 01, 1988
DADE(R) CK/LD COMPREHENSIVE ELECTRO. CONTROL
K880175 · JJY
Baxter Healthcare Corp
Chemistry · 46d