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
100801–100824 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 25, 1995
ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE
K946005 · FMT
Astral, Ltd.
General Hospital · 290d
Cleared Sep 25, 1995
ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE
K950143 · FMT
Astral, Ltd.
General Hospital · 255d
Cleared Sep 25, 1995
FASGUIDE
K951159 · DQY
Target Therapeutics
Cardiovascular · 195d
Cleared Sep 25, 1995
KOOL GARD SINGLES GOWN
K952114 · FYC
American Threshold Industries, Inc.
General Hospital · 143d
Cleared Sep 25, 1995
BARRIER GOWN, KOOL-GARD BACKLESS GOWN
K952115 · FYC
American Threshold Industries, Inc.
General Hospital · 143d
Cleared Sep 25, 1995
DISPOSABLE NEUROLOGY ELECTRODES NEUROLINE 7 30 01-K
K952176 · GXY
Medicotest, Inc.
Neurology · 140d
Cleared Sep 25, 1995
HEMA-TROL Q-CHECK
K952385 · JJY
Medical Specialties Intl., Inc.
Hematology · 126d
Cleared Sep 25, 1995
MEDI-AID BASAL THERMOMETER
K952756 · LHD
Polymedica Industries, Inc.
Obstetrics & Gynecology · 101d
Cleared Sep 25, 1995
OXY/STAR LOW FLOW BLENDER
K952878 · BZR
Infrasonics Corp.
Anesthesiology · 94d
Cleared Sep 25, 1995
ACCESS ULTRASENSITIVE INSULIN ASSAY
K953084 · CFP
Bio-Rad Laboratories, Inc.
Chemistry · 84d
Cleared Sep 25, 1995
BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER
K953239 · JJE
Boehringer Mannheim Corp.
Chemistry · 76d
Cleared Sep 25, 1995
ABBOTT AXSYM PROLACTIN(MODIFICATION)
K953657 · CFT
Abbott Mfg., Inc.
Chemistry · 69d
Cleared Sep 25, 1995
AXSYM DIGOXIN II
K953718 · KXT
Abbott Laboratories
Toxicology · 47d
Cleared Sep 25, 1995
AXSYM PHENYTOIN II
K953840 · LGR
Abbott Laboratories
Toxicology · 40d
Cleared Sep 25, 1995
ACTI-FLEX ARTERIAL EXTENSION SET
K954035 · CBT
R-Group Intl.
Anesthesiology · 28d
Cleared Sep 22, 1995
KIMONO (CONDOMS)
K943064 · HIS
Mayer Laboratories
Obstetrics & Gynecology · 476d
Cleared Sep 22, 1995
MAXX
K946376 · HIS
Mayer Laboratories
Obstetrics & Gynecology · 282d
Cleared Sep 22, 1995
MICROSOUND 6.6F DIAGNOSTIC IMAGING CATHETER MODEL 50302, INTRAVASCULAR...
K950276 · IYO
Endosonics Corp.
Radiology · 242d
Cleared Sep 22, 1995
EGNELL ELITE
K950531 · HGX
Hollister, Inc.
Obstetrics & Gynecology · 227d
Cleared Sep 22, 1995
COLLAPSIBLE HYPODERMIC SYRINGE
K951980 · FMF
Roman Vladimirsky
General Hospital · 148d
Cleared Sep 22, 1995
BASIS DIGITAL THERMOMETER
K952159 · FLL
Polymedica Industries, Inc.
General Hospital · 137d
Cleared Sep 22, 1995
WELCH ALLYN VIDEO EPISCOPE
K952835 · KZF
Welch Allyn, Inc.
General Hospital · 94d
Cleared Sep 22, 1995
THE TULIP J DISSECTOR
K952965 · GCJ
The Tulip Mfg. Co.
General & Plastic Surgery · 87d
Cleared Sep 22, 1995
PERI-PUSHER
K953046 · IYE
Diacor, Inc.
Radiology · 84d