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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
115921–115944 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 23, 1992
NO-SCALPEL VASCETOMY INSTRUMENTS
K922971 · KOA
Pilling Co.
Gastroenterology & Urology · 96d
Cleared Sep 23, 1992
ENCORE TEST STRIPS
K923018 · CFR
Heraeus Kulzer, Inc.
Chemistry · 92d
Cleared Sep 23, 1992
DANPLEX SCREENING AUDIOMETER
K923074 · EWO
Life-Tech Intl., Inc.
Ear, Nose, Throat · 90d
Cleared Sep 23, 1992
3M LASER IMAGER MODEL 969
K923075 · LMC
3M Medical Products Group
Radiology · 90d
Cleared Sep 23, 1992
WRIST RESTRAINT FOR GE9800 C.T. TABLES
K923108 · JAK
Cook, Inc.
Radiology · 90d
Cleared Sep 23, 1992
ADULT CHIN STRAP FOR CT TABLES
K923109 · JAK
Cook, Inc.
Radiology · 90d
Cleared Sep 23, 1992
SCAN BAND
K923110 · JAK
Cook, Inc.
Radiology · 90d
Cleared Sep 23, 1992
ARM EXTENDER FOR CT TABLES
K923111 · JAK
Cook, Inc.
Radiology · 90d
Cleared Sep 23, 1992
ANGIO-BAND
K923112 · IZI
Cook, Inc.
Radiology · 90d
Cleared Sep 23, 1992
HEAD RESTRAINT FOR CT TABLES
K923114 · JAK
Cook, Inc.
Radiology · 90d
Cleared Sep 23, 1992
CSL X-RAY IMAGESCOPE
K923137 · JAA
Csi Opto-Electronics Corp.
Radiology · 86d
Cleared Sep 23, 1992
BAXTER SENSOR CORONARY GUIDEWIRE
K923240 · DQX
Baxter Healthcare Corp
Cardiovascular · 83d
Cleared Sep 23, 1992
TECHNICON IMMUNO 1 SYSTEM TOTAL TRIIODOTHYRONINE
K923258 · CDP
Heraeus Kulzer, Inc.
Chemistry · 83d
Cleared Sep 23, 1992
ITC HEARING AID CLUB MODEL LM50H
K923293 · ESD
Club Hearing Instruments A/S
Ear, Nose, Throat · 83d
Cleared Sep 23, 1992
BTE HEARING AID CLUB MODEL: ST60
K923294 · ESD
Club Hearing Instruments A/S
Ear, Nose, Throat · 83d
Cleared Sep 23, 1992
ITC HEARING AID CLUB MODEL LM40
K923295 · ESD
Club Hearing Instruments A/S
Ear, Nose, Throat · 83d
Cleared Sep 23, 1992
BTE HEARING AID CLUB MODEL ST70
K923296 · ESD
Club Hearing Instruments A/S
Ear, Nose, Throat · 83d
Cleared Sep 23, 1992
COULTER BETA-2 MICROGLOBULIN IMMUNOASSAY
K923421 · JZG
Coulter Corp.
Immunology · 72d
Cleared Sep 23, 1992
COX DISPOSABLE RETRIEVAL DEVICES
K923489 · OCZ
Cox Medical Ent., Inc.
Gastroenterology & Urology · 70d
Cleared Sep 23, 1992
LIFE-TEL T.R.S.
K923493 · DXH
Raco Products Co.
Cardiovascular · 70d
Cleared Sep 23, 1992
COX DISPOSABLE ENDOSCOPE CLEANING BRUSH
K923672 · FEB
Cox Medical Ent., Inc.
General Hospital · 63d
Cleared Sep 23, 1992
ONE DIRECTIONAL CLEANING BRUSH
K923687 · FEB
Endoscopy Support Services, Inc.
General Hospital · 62d
Cleared Sep 23, 1992
BREAST LESION LOCALIZATION NEEDLE
K924270 · GDF
Core Medical, Inc.
General & Plastic Surgery · 30d
Cleared Sep 23, 1992
CONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATH
K924407 · EXJ
Coloplast A/S
Gastroenterology & Urology · 29d