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
135985–136008 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 31, 1988
SPERM WASHING MEDIUM #9983 & MODIFIED #9984
K874668 · HDR
Irvine Scientific
Obstetrics & Gynecology · 139d
Cleared Mar 31, 1988
MASCOT STETHOSCOPE PROBE
K874726 · DQD
Imex Medical Systems, Inc.
Cardiovascular · 134d
Cleared Mar 31, 1988
INDISTRIP (STERILIZATION PROCESS INDICATOR)
K875193 · JOJ
Indilab, Inc.
General Hospital · 105d
Cleared Mar 31, 1988
VZV TEST
K875358 · GQX
Gull Laboratories, Inc.
Microbiology · 91d
Cleared Mar 31, 1988
TAKEDA MEDICAL AUTO. AMBU. BLOOD PRESS. METER/2420
K880079 · DSK
A&D Engineering, Inc.
Cardiovascular · 80d
Cleared Mar 31, 1988
MRVP BROTH
K880116 · JSE
Hardy Media
Microbiology · 85d
Cleared Mar 31, 1988
MOELLERS DECARBOXYLASE, ONITHINE
K880119 · JSF
Hardy Media
Microbiology · 85d
Cleared Mar 31, 1988
MOELLERS DECARBOXYLASE, LYSINE
K880120 · JSF
Hardy Media
Microbiology · 85d
Cleared Mar 31, 1988
MOELLERS DECARBOXYLASE, BASE
K880121 · JSH
Hardy Media
Microbiology · 85d
Cleared Mar 31, 1988
MIDDLEBROOK 7H9 BROTH
K880122 · KZI
Hardy Media
Microbiology · 85d
Cleared Mar 31, 1988
LOWENSTEIN-JENSEN SLANT
K880123 · JSJ
Hardy Media
Microbiology · 85d
Cleared Mar 31, 1988
LOWENSTEIN-JENSEN, W/NACL
K880124 · JSJ
Hardy Media
Microbiology · 85d
Cleared Mar 31, 1988
LOWENSTEIN-JENSEN, SELECTIVE
K880125 · JSI
Hardy Media
Microbiology · 85d
Cleared Mar 31, 1988
LAURYL TRYPTOSE BROTH
K880126 · JSF
Hardy Media
Microbiology · 85d
Cleared Mar 31, 1988
LOWENSTEIN-JENSEN, GRUFT
K880131 · KZI
Hardy Media
Microbiology · 85d
Cleared Mar 31, 1988
MIL MEDIUM
K880133 · JSE
Hardy Media
Microbiology · 85d
Cleared Mar 31, 1988
MIDDLEBROOK 7H11 AGAR
K880134 · KZI
Hardy Media
Microbiology · 85d
Cleared Mar 31, 1988
TRANSRECTAL PROBE BD65S-TR
K880219 · IYO
Elscint, Inc.
Radiology · 71d
Cleared Mar 31, 1988
TRI-STAGE (TS-I) DENTAL IMPLANT
K880220 · DZE
Tri-Stage, Inc.
Dental · 71d
Cleared Mar 31, 1988
'HILT-WAY' RESUSCITATOR
K880241 · CAE
Medifield , Ltd.
Anesthesiology · 71d
Cleared Mar 31, 1988
CHICOPEE ADULT INCONTINENCE SHIELDS
K880338 · EYQ
Chicopee, Inc.
Gastroenterology & Urology · 65d
Cleared Mar 31, 1988
TRANSBOND LIGHT CURED ORTHODONTIC ADHESIVE
K880393 · DYH
Unitek Corp.
Dental · 62d
Cleared Mar 31, 1988
MAESTRO(R) MODEL 119, SINGLE-CHAMBER PACEMAKER
K880422 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 59d
Cleared Mar 31, 1988
MEDICOMP STRAIGHT SWIVEL ADAPTOR
K880434 · BZA
Medicomp, Inc.
Anesthesiology · 59d