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
100465–100488 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 17, 1995
INCARE PRS 9300 PELVIC FL THERA SYST/TREAT URI INC
K930530 · KPI
Hollister, Inc.
Gastroenterology & Urology · 987d
Cleared Oct 17, 1995
INDURENT GEL
K935892 · ELW
Zhermack Dental Production
Dental · 735d
Cleared Oct 17, 1995
BOBES SLIT LAMP
K945445 · HJO
Bobes S.A.
Ophthalmic · 344d
Cleared Oct 17, 1995
MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM
K950073 · GSA
Shared Systems, Inc.
Microbiology · 281d
Cleared Oct 17, 1995
PP-SPF1 / PP-SPF2
K951665 · FPA
Patriot Products, Inc.
General Hospital · 190d
Cleared Oct 17, 1995
MEDTEC AUTOBLOT 2000
K951753 · JQW
Medtec, Inc.
Microbiology · 183d
Cleared Oct 17, 1995
EML105 ELECTROLYTE METABOLITE ANALYZER
K952621 · CGA
Radiometer America, Inc.
Chemistry · 131d
Cleared Oct 17, 1995
QD BILATERAL BREAST COIL
K953262 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 96d
Cleared Oct 17, 1995
TRI-STAR UNIVERSAL I/A PHACO PAK
K953359 · HQC
Tri-Star Ophthalmic
Ophthalmic · 92d
Cleared Oct 17, 1995
ACCUPUMP 901 (MODEL NUMBERS 50 & 100)
K953382 · FRN
Pharmaceutical Infusion Technologies,...
General Hospital · 90d
Cleared Oct 17, 1995
SONOGEL
K953468 · IYO
Sonotech, Inc.
Radiology · 85d
Cleared Oct 17, 1995
PLUM XL INFUSION PUMP (MODIFICATION)
K953660 · FRN
Abbott Laboratories
General Hospital · 77d
Cleared Oct 17, 1995
MODIFIED VERSAPORT
K954108 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 75d
Cleared Oct 17, 1995
SNOR-X MOUTH GUARD
K954324 · LRK
Snorex, Inc.
Dental · 29d
Cleared Oct 17, 1995
URODYNAMICS TUBING AND INFUSION SETS
K954341 · FEN
Life-Tech Intl., Inc.
Gastroenterology & Urology · 29d
Cleared Oct 17, 1995
AMERICAN DENTAL PRODUCTS TWO PASTE ADHESIVE ORTHODONTIC BONDING SYSTEM...
K954372 · DYH
American Dental Products, Inc.
Dental · 28d
Cleared Oct 16, 1995
VENTURI VENTILATOR
K943412 · CBK
Cardiopulmonary Corp.
Anesthesiology · 459d
Cleared Oct 16, 1995
ECOTABS
K950587 · DRX
Msb , Ltd.
Cardiovascular · 249d
Cleared Oct 16, 1995
MEDELAS BREAST PUMP
K950750 · HGX
Medela, Inc.
Obstetrics & Gynecology · 241d
Cleared Oct 16, 1995
ADEL 5000
K950889 · HDD
Stryker Corp.
Obstetrics & Gynecology · 230d
Cleared Oct 16, 1995
CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST
K951754 · JSO
Hardy Diagnostics
Microbiology · 182d
Cleared Oct 16, 1995
CRYOPRESS
K951769 · IRP
Grimm Scientific Industries, Inc.
Physical Medicine · 182d
Cleared Oct 16, 1995
ECO CHECK (ECOVALVE AND OXYGEN MONITOR)
K951882 · CAW
Airsep Corp.
Anesthesiology · 196d
Cleared Oct 16, 1995
STERI-OSS IMMEDIATE PLACEMENT IMPLANT
K952917 · DZE
Steri-Oss, Inc.
Dental · 112d