FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
82609–82632 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 11, 2000
HEADLAMP HL2000.
K994362 · FSR
Angiolaz, Inc.
Ophthalmic · 136d
Cleared May 10, 2000
POSI-LINK
K000472 · FPA
Icu Medical, Inc.
General Hospital · 86d
Cleared May 10, 2000
RUMBAR DRAINAGE SYSTEM
K000514 · JXG
Phoenix Biomedical Corp.
Neurology · 84d
Cleared May 10, 2000
KEYSTONE HIP
K000521 · LPH
Encore Orthopedics, Inc.
Orthopedic · 84d
Cleared May 10, 2000
PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M
K001139 · DYB
Biosense Webster, Inc.
Cardiovascular · 30d
Cleared May 10, 2000
COLORADO II SPINAL SYSTEM
K991031 · MNH
Sofamor Danek USA,Inc.
Orthopedic · 408d
Cleared May 09, 2000
PSK ENDOSCOPE CLEANING SYSTEM
K000216 · FEB
Psk Connectors Pty, Ltd.
General Hospital · 106d
Cleared May 09, 2000
GO MEDICAL BALLOON INFUSION SYSTEM
K000263 · MEB
Go Medical Industries Pty. , Ltd.
General Hospital · 102d
Cleared May 09, 2000
MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP
K000328 · FRN
Medex, Inc.
General Hospital · 97d
Cleared May 09, 2000
FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290
K000451 · FJK
Fresenius Medical Care North America
Gastroenterology & Urology · 88d
Cleared May 09, 2000
VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES
K000457 · HMX
Retinalabs.Com
Ophthalmic · 88d
Cleared May 09, 2000
RHIGENE MESACUP2 TEST- SSA
K000749 · LLL
Rhigene, Inc.
Immunology · 62d
Cleared May 09, 2000
RHIGENE MESACUP2 TEST- SCL-70
K000750 · LLL
Rhigene, Inc.
Immunology · 62d
Cleared May 09, 2000
RHIGENE MESACUP2 TEST- SSB
K000751 · LLL
Rhigene, Inc.
Immunology · 62d
Cleared May 09, 2000
RHIGENE MESACUP2 TEST- RNP
K000752 · LKO
Rhigene, Inc.
Immunology · 62d
Cleared May 09, 2000
RHIGENE MESACUP2 TEST- SM
K000755 · LKP
Rhigene, Inc.
Immunology · 62d
Cleared May 09, 2000
POWDER FREE STERILE LATEX EXAMINATION GLOVES
K001141 · LYY
Allegiance Healthcare Corp.
General Hospital · 29d
Cleared May 09, 2000
TROJAN EXTRA LARGE LATEX CONDOM
K001212 · HIS
Armkel, LLC
Obstetrics & Gynecology · 25d
Cleared May 09, 2000
EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I
K001241 · FDF
The Olympus Optical Co.
Gastroenterology & Urology · 21d
Cleared May 09, 2000
MEDI-CULT BLASTOCYST FREEZING & THAWING PACKS, INTERNAL CATALOG NUMBERS...
K991471 · MQL
Medicult A/S
Obstetrics & Gynecology · 391d
Cleared May 09, 2000
MEDI-CULT EMBRYO FREEZING MEDIUM INTERNAL CATAGLOG NUMBERS 1079
K991472 · MQL
Medicult A/S
Obstetrics & Gynecology · 391d
Cleared May 09, 2000
NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240
K994140 · MSW
Nichols Institute Diagnostics
Immunology · 153d
Cleared May 08, 2000
TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001
K000416 · MPA
Retinalabs.Com
Ophthalmic · 90d
Cleared May 08, 2000
SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003
K000420 · MRH
Retinalabs.Com
Ophthalmic · 90d