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
166393–166416 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 04, 1980
TONOTEST BLOOD PRESSURE MONITOR
K800904 · DXN
Retlif, Inc.
Cardiovascular · 44d
Cleared Jun 04, 1980
AUDIONICS PB MAX HEARING AID
K800940 · ESD
Audionics Corp.
Ear, Nose, Throat · 43d
Cleared Jun 04, 1980
TANIT HOME SUNTANNING UNIT
K800950 · FTC
Tanit, Inc.
Radiology · 42d
Cleared Jun 04, 1980
HOWMEDICA WHITE C&B ALLOY
K801009 · EJS
Dental Laboratory Products Div.
Dental · 37d
Cleared Jun 04, 1980
SURGICAL MASK
K801036 · FXX
American Threshold Industries, Inc.
General Hospital · 33d
Cleared Jun 04, 1980
PULSED GALVANIC STIMULATOR, 450-DYNAMAX
K801053 · IPF
U.S. Medical Corp.
Physical Medicine · 30d
Cleared Jun 04, 1980
EDP 1200 ULTRASONIC B-SCANNER
K801056 · IYO
Technicare Corp.
Radiology · 29d
Cleared Jun 04, 1980
HIGH RESOLUTION 10CM DIAG. ULTRA. SCANNE
K801060 · IYO
Smithkline Diagnostics, Inc.
Radiology · 29d
Cleared Jun 04, 1980
BEHIND-THE-EAR HEARING AID SERIES G
K801062 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 29d
Cleared Jun 04, 1980
PERFECTEMP OPHTHALMIC CAUTERY
K801078 · HQP
Medical Products Development, Inc.
Ophthalmic · 28d
Cleared Jun 04, 1980
SAMPLING KIT
K801146 · CBT
Pharmaseal Laboratories
Anesthesiology · 22d
Cleared Jun 04, 1980
PEDIATRIC ARTERIAL BLOOD FILTER #AF-5
K801147 · DTM
Bentley Laboratories, Inc.
Cardiovascular · 22d
Cleared Jun 04, 1980
CONPHAR WALL MODEL MERCURY SPHYGMOMAN.
K801182 · DXQ
Conphar, Inc.
Cardiovascular · 19d
Cleared Jun 04, 1980
CONPHAR DUAL HEAD STETHOSCOPE
K801183 · LDE
Conphar, Inc.
Cardiovascular · 19d
Cleared Jun 04, 1980
CONPHAR SPRAGUE RAPPAPORT STETHOSCOPE
K801184 · LDE
Conphar, Inc.
Cardiovascular · 19d
Cleared Jun 04, 1980
CONPHAR BOWLS STETHOSCOPE
K801185 · LDE
Conphar, Inc.
Cardiovascular · 16d
Cleared Jun 04, 1980
CONPHAR SUPERTONE STETHOSCOPE
K801189 · DQD
Conphar, Inc.
Cardiovascular · 16d
Cleared Jun 04, 1980
VOLDYNE VOLUMETRIC INCENTIVE DEEP BR. EX
K801199 · BWF
Chesebrough-Pond'S U.S.A. Co.
Anesthesiology · 16d
Cleared Jun 04, 1980
SAMPLING MANIFOLD H530
K801200 · DTL
C.R. Bard, Inc.
Cardiovascular · 16d
Cleared Jun 04, 1980
ABCO PEDIATRIC STETHOSCOPE
K801215 · LDE
Abco Dealers, Inc.
Cardiovascular · 15d
Cleared Jun 04, 1980
BONDALCAP (SILICO-PHOSPHATE)
K801228 · EMA
Vivadent (Usa), Inc.
Dental · 12d
Cleared Jun 04, 1980
BONDALCAP (CARBOXYLATE)
K801229 · EMA
Vivadent (Usa), Inc.
Dental · 12d
Cleared Jun 04, 1980
BUILT-IN TEMPERATURE MONITORING
K801240 · DTZ
Bentley Laboratories, Inc.
Cardiovascular · 8d
Cleared Jun 04, 1980
NON-CONDUCTIVE, SINGLE USE FACE MASK #55
K801251 · BSJ
Vital Signs, Inc.
Anesthesiology · 7d