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
166513–166536 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 28, 1980
RIAUSE AUTO PROCESSOR
K801030 · JQW
Electro-Nucleonics Laboratories, Inc.
Chemistry · 27d
Cleared May 28, 1980
CENTRIA SYSTEM 2 AUTOMATED METHOD/RIA
K801037 · LCI
Union Carbide Corp.
Chemistry · 26d
Cleared May 28, 1980
ILLUMINATED SPECULUM
K801058 · FXF
Designs For Vision, Inc.
General & Plastic Surgery · 22d
Cleared May 28, 1980
TELESONIC, SOUNDEX & GENERIC V-101
K801066 · ESD
Telesonic, Inc.
Ear, Nose, Throat · 22d
Cleared May 28, 1980
TELESONIC, GENERIC & SOUNDEX C-102
K801067 · ESD
Telesonic, Inc.
Ear, Nose, Throat · 22d
Cleared May 28, 1980
NORMCAP CD-102, CARBON DIOXIDE ANALYZER
K801083 · CCL
Instrumentarium-Datex
Anesthesiology · 21d
Cleared May 28, 1980
P-NITROPHENYL PHOSPHATE
K801086
Macomb Chemical Co.
Chemistry · 21d
Cleared May 28, 1980
J.T. BAKER NEPHELOMETER
K801089 · JQX
J.T. Baker Chemical Co.
Chemistry · 20d
Cleared May 28, 1980
ANALOR FOUR-DENTAL MODEL
K801100 · BSZ
Narco Mckesson Co.
Anesthesiology · 19d
Cleared May 28, 1980
COMPALOR-DENTAL MODEL
K801103 · BSZ
Narco Mckesson Co.
Anesthesiology · 19d
Cleared May 28, 1980
DAHLBERG HEARING AID MODEL MEH
K801114 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 16d
Cleared May 28, 1980
DAHLBERG HEARING AID MODEL MEL
K801115 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 16d
Cleared May 28, 1980
AMES TDA AMIKACIN
K801130 · KLQ
Miles Laboratories, Inc.
Toxicology · 16d
Cleared May 28, 1980
ANGIO-FLO MONITORING KIT
K801173 · KRA
Hospital Products Co.
Cardiovascular · 12d
Cleared May 28, 1980
FIBER OPTIC LIGHT SOURCE
K801176 · EQH
Aspen Laboratories, Inc.
Ear, Nose, Throat · 12d
Cleared May 28, 1980
ANESTHESIA BREATHING CIRCUITS
K801191 · CAI
Airlife, Inc.
Anesthesiology · 9d
Cleared May 28, 1980
LIBCO SUNGLASSES
K801196 · HQY
Libco Eyewear, Inc.
Ophthalmic · 13d
Cleared May 28, 1980
HOLLOW BASKET TITANIUM DENTAL IMPLANT
K801208 · ELE
Colmed, Ltd.
Dental · 8d
Cleared May 28, 1980
CONCEPT ENDOTRACHEAL TUBE
K801213 · BTR
Concept, Inc.
Anesthesiology · 8d
Cleared May 28, 1980
DEN-MAT DENTIN BONDING AGENT
K801216 · KLE
Den-Mat Corp.
Dental · 7d
Cleared May 23, 1980
CYCLOPAC CP100 TENS BANDAGE
K800576 · GZJ
Cyclotechnical Medical Indust., Inc.
Neurology · 69d
Cleared May 23, 1980
LIBERATOR/STROLLER II SYSTEM
K800742 · BYJ
Cryogenic Assoc.
Anesthesiology · 50d
Cleared May 23, 1980
WINDSOR
K800865 · BZR
Trident Dental, Inc.
Anesthesiology · 37d
Cleared May 23, 1980
LAB-TEK ANACULT ANAEROBIC CULTURE CHAMBE
K800899 · KZJ
Miles Laboratories, Inc.
Microbiology · 35d