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
82105–82128 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 05, 2000
MODIFICATION TO CARTO EP NAVIGATION SYSTEM
K000190 · DQK
Biosense Webster, Inc.
Cardiovascular · 113d
Cleared May 05, 2000
CARTO EP NAVIGATION SYSTEM
K000248 · DQK
Biosense Webster, Inc.
Cardiovascular · 99d
Cleared May 05, 2000
POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111
K000386 · FFX
Medtronic Functional Diagnostics A/S
Gastroenterology & Urology · 88d
Cleared May 05, 2000
YOSHIDA WAVE PICT CAM INTRAORAL CAMERA, SIGMA BIOMEDICS SIGMACAM INTRAORAL...
K000577 · EIA
The Yoshida Dental Mfg. Co., Ltd.
Dental · 73d
Cleared May 05, 2000
SERIM LEUKOCYTE ESTERASE TEST STRIPS
K000578 · LJX
Serim Research Corp.
Hematology · 73d
Cleared May 05, 2000
SYNCHRON SYSTEMS AMPHETAMINE REAGENT
K000606 · DKZ
Beckman Coulter, Inc.
Toxicology · 72d
Cleared May 05, 2000
PIONEER SURGICAL TECHNOLOGY EXTENDED GTR, MODEL 501-601
K000734 · KTT
Pioneer Surgical Technology
Orthopedic · 59d
Cleared May 05, 2000
CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE
K000897 · GKZ
Bd Biosciences
Hematology · 45d
Cleared May 05, 2000
BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE...
K001100 · DSB
Cardiodynamics International Corp.
Cardiovascular · 30d