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
168625–168648 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 04, 1979
FETASONDE UTERINE ACTIVITY MONITOR
K791038 · HGM
Roche Medical Electronics, Inc.
Obstetrics & Gynecology · 91d
Cleared Sep 04, 1979
FETASONDE FETAL HEART RATE VARIABILITY
K791039 · HGM
Roche Medical Electronics, Inc.
Obstetrics & Gynecology · 91d
Cleared Sep 04, 1979
HEMATRAK ABNORMAL RECOGNITION
K791041 · GKZ
Geometric Data, Div. Smithkline Corp.
Hematology · 91d
Cleared Sep 04, 1979
GLUCOSE GOD-PAP TRINDER METHOD TEST KIT
K791066 · CGA
Fermco Biochemics, Inc.
Chemistry · 84d
Cleared Sep 04, 1979
BILI-DOSIMETER
K791114 · LBI
Olympic Medical Corp.
General Hospital · 81d
Cleared Sep 04, 1979
PSORALITE SERIES 30,000
K791116 · KGL
Paul B. Elder Co.
General & Plastic Surgery · 81d
Cleared Sep 04, 1979
FLU-VEN TK-2
K791130 · KSB
Venospital, Inc.
Hematology · 78d
Cleared Sep 04, 1979
FLU VEN TR-1
K791131 · KSB
Venospital, Inc.
Hematology · 78d
Cleared Sep 04, 1979
GELSKIN
K791162 · ILO
Spenco Medical Corp.
Physical Medicine · 71d
Cleared Sep 04, 1979
TSH RIA KIT
K791217 · JLW
Antibodies, Inc.
Chemistry · 64d
Cleared Sep 04, 1979
DAC-CEL T4
K791231 · CDX
Burroughs Wellcome Co.
Chemistry · 64d
Cleared Sep 04, 1979
DAC-CEL T3
K791232 · CDP
Burroughs Wellcome Co.
Chemistry · 64d
Cleared Sep 04, 1979
FIBRO-TEC TEST KIT
K791358 · GHH
Calbiochem-Behring Corp.
Hematology · 42d
Cleared Sep 04, 1979
KODAK ORTHO M FILM
K791360 · IWZ
Eastman Kodak Company
Radiology · 42d
Cleared Sep 04, 1979
ELECTROSURGICAL CUT AND COAGU ACCESSORY
K791362 · GEI
Intermedics, Inc.
General & Plastic Surgery · 56d
Cleared Sep 04, 1979
IMPLANTABLE PULSE GENERATOR PACEMAKER
K791417 · DXY
Intermedics, Inc.
Cardiovascular · 39d
Cleared Sep 04, 1979
SIMMONS CITRATE AGAR
K791474 · JSF
Isle Media and Sterile Products, Inc.
Microbiology · 39d
Cleared Sep 04, 1979
HEKTOEN ENTERIC AGAR
K791475 · JSI
Isle Media and Sterile Products, Inc.
Microbiology · 39d
Cleared Sep 04, 1979
.E.C MEDIUM (ESCHERICHIA COLI MEDIUM)
K791476 · JSF
Isle Media and Sterile Products, Inc.
Microbiology · 39d
Cleared Sep 04, 1979
XLD AGAR (XYLASE LYSINE DESOXY AGAR)
K791477 · JSI
Isle Media and Sterile Products, Inc.
Microbiology · 36d
Cleared Sep 04, 1979
FLUID THIOGLYCOLLATE MEDIUM
K791478 · JSC
Isle Media and Sterile Products, Inc.
Microbiology · 36d
Cleared Sep 04, 1979
ENDO AGAR
K791479 · JSI
Isle Media and Sterile Products, Inc.
Microbiology · 36d
Cleared Sep 04, 1979
BIOLITE CARBON COATED DENTAL IMPLANT
K791491 · DZE
Carbomedics, Inc.
Dental · 29d
Cleared Sep 04, 1979
QUANTIMUNE TOBRAMYCIN RIA RADIOIMMUNO
K791502 · KLB
Bio-Rad
Toxicology · 27d