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
145441–145464 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 21, 1986
TRANSFER-TRAX (TM) SPLINT TRACTION
K855179 · HST
Comfortex, Inc.
Neurology · 26d
Cleared Jan 21, 1986
FIBERLASE 100 ND: YAG MEDICAL LASER SYSTEM
K855197 · LNK
Laser Media
Gastroenterology & Urology · 26d
Cleared Jan 21, 1986
ASAHI AM SERIES DIALYZERS
K855212 · FJI
Advocacy International, Ltd.
Gastroenterology & Urology · 22d
Cleared Jan 21, 1986
SUSPENDER ORTHOPEDIC SUSPENSION DEVICE
K860037 · HST
Comfortex, Inc.
Neurology · 15d
Cleared Jan 21, 1986
BIO SPEC GRAMAFLUOR TEST KIT
K860091 · JTO
Bio Spec, Inc.
Microbiology · 11d
Cleared Jan 17, 1986
PLT-4 PLATELET ANALYZER
K853722 · GKL
Texas Intl. Laboratories, Inc.
Hematology · 134d
Cleared Jan 17, 1986
KODAK EKTACHEM HDL CHOLESTEROL KIT
K854426 · CHH
Eastman Kodak Company
Chemistry · 73d
Cleared Jan 17, 1986
CREATININE PAP
K854766 · JFY
Boehringer Mannheim Corp.
Chemistry · 51d
Cleared Jan 17, 1986
RA 80 EIKEN
K854820 · DHR
Syn-Kit, Inc.
Immunology · 45d
Cleared Jan 17, 1986
CANTROL ELECTROPHORESIS CONTROL
K854931 · JJY
Canyon Diagnostics, Inc.
Chemistry · 38d
Cleared Jan 17, 1986
TDXR 5-HIAA (URINE)
K854946 · CDA
Abbott Laboratories
Chemistry · 38d
Cleared Jan 17, 1986
CANTROL CK/MB CONTROL
K855006 · JJT
Canyon Diagnostics, Inc.
Chemistry · 35d
Cleared Jan 17, 1986
ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL
K855225 · JJX
Boehringer Mannheim Corp.
Chemistry · 18d
Cleared Jan 16, 1986
MYOPACH ULTRASONIC PACHOMETER
K844112 · IYO
Myocure, Inc.
Radiology · 450d
Cleared Jan 16, 1986
CENTRAL VEIN CATHETERIZATION TRAY
K852642 · FDZ
Teleflexmedical, Inc.
Gastroenterology & Urology · 209d
Cleared Jan 16, 1986
HEARING AID ANALYSIS SYSTEM
K853271 · ETW
Robert Bosch Corp.
Ear, Nose, Throat · 164d
Cleared Jan 16, 1986
BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT
K853652 · DRR
Fisher Imaging Corp.
Cardiovascular · 135d
Cleared Jan 16, 1986
MP0400 ADULT, PERISTALIC INFUSION PUMP
K853814 · FRN
Medex, Inc.
General Hospital · 126d
Cleared Jan 16, 1986
SONOLINE LX
K853946 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 114d
Cleared Jan 16, 1986
ANGIOGRAPHY CATHETERS
K854018 · DQO
Micor, Inc.
Cardiovascular · 108d
Cleared Jan 16, 1986
INFANT LIFE SUPPORT MODULE-20
K854065 · FPL
Intl. Biomedics, Inc.
General Hospital · 104d
Cleared Jan 16, 1986
CRAIGWELL AID FITTING SYSTEM AFS
K854125 · EWO
Craigwell Electronics, Ltd.
Ear, Nose, Throat · 99d
Cleared Jan 16, 1986
CRAIGWELL MASTER HEARING AID MHA
K854126 · KHL
Craigwell Electronics, Ltd.
Ear, Nose, Throat · 99d
Cleared Jan 16, 1986
JELLIA SKIN 1001 & LUBRICATED MILLION CONDOMS
K854247 · HIS
M/S Seohung Industrial Co., Ltd.
Obstetrics & Gynecology · 87d