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
170017–170040 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 10, 1979
RIA KIT, KANAMYCIN
K782125 · KJI
Diagnostic Products Corp.
Toxicology · 14d
Cleared Jan 10, 1979
BRUSH/SPONGE, DISPOSABLE
K782172 · GEC
Dexide, Inc.
General & Plastic Surgery · 12d
Cleared Jan 10, 1979
SURGERY BRUSH
K782173 · GEC
Dexide, Inc.
General & Plastic Surgery · 12d
Cleared Jan 08, 1979
HEATER, OXIMETER SYSTEM
K781879 · DQA
Oximetrix, Inc.
Anesthesiology · 63d
Cleared Jan 08, 1979
AUTORANGE
K781997 · ISD
Tri W-G, Inc.
Physical Medicine · 39d
Cleared Jan 08, 1979
PADS, MINI, MAXI DEODORANT
K782111 · HHL
Intl. Playtex, Inc.
Obstetrics & Gynecology · 21d
Cleared Jan 08, 1979
PADS, MINI, MAXI
K782112 · HHD
Intl. Playtex, Inc.
Obstetrics & Gynecology · 21d
Cleared Jan 08, 1979
HR UNIT
K782148 · IQP
Parke-Davis Co.
Physical Medicine · 17d
Cleared Jan 05, 1979
LVV OPTION
K781855 · DXG
Honeywell, Inc.
Cardiovascular · 60d
Cleared Jan 05, 1979
WRITER, GEMINI-3
K781867 · DSF
C-V Monitors Corp.
Cardiovascular · 63d
Cleared Jan 05, 1979
RECORDER, STRIP CHART WITH PRINTER
K781873 · DSF
Midwest Analog & Digital, Inc.
Cardiovascular · 63d
Cleared Jan 05, 1979
STIMULATOR, ELECTRICAL NERVE
K782127 · GZJ
Somatronics, Inc.
Neurology · 9d
Cleared Jan 05, 1979
DISPOSABLE SURGICAL INSTRUMENT TIP
K782144 · KCT
Anago, Inc.
General Hospital · 9d
Cleared Jan 04, 1979
TRAY, AUXILLARY BLOCK
K782069 · CAZ
Pharmaseal Div., Baxter Healthcare Corp.
Anesthesiology · 22d
Cleared Jan 04, 1979
MONITOR, HEART RATE MODEL 105
K782088 · DRT
Roche Medical Electronics, Inc.
Cardiovascular · 21d
Cleared Jan 04, 1979
MONITOR, HEART RATE MODEL 103
K782089 · DRT
Roche Medical Electronics, Inc.
Cardiovascular · 21d
Cleared Jan 03, 1979
ULTRASOUND BREAST SCANNING DEVICE
K781177 · IYO
Life Instrument Corp.
Radiology · 181d
Cleared Jan 03, 1979
AST
K781784 · CIT
Gilford Diagnostics
Chemistry · 76d
Cleared Jan 03, 1979
CONTROL SET, EMIT METHOTREXATE
K781827 · LAS
Syva Co.
Toxicology · 65d
Cleared Jan 03, 1979
TEST SET, 125 I-DIGOXIN
K781834 · DNL
Wien Laboratories, Inc.
Toxicology · 65d
Cleared Jan 03, 1979
RIA, QUANTIMUNE E3
K781850 · CGI
Bio-Rad
Chemistry · 62d
Cleared Jan 03, 1979
RIA KIT, QUANTITOPE T3 UPTAKE
K781905 · KHQ
Kallestad Laboratories, Inc.
Chemistry · 51d
Cleared Jan 03, 1979
BILIRUBIN, DINGLE VALVE DPD
K781921 · CIG
Boehringer Mannheim Corp.
Chemistry · 51d
Cleared Jan 03, 1979
ANALYSIS SYSTEM, PREP SAMPLE
K781941 · DOZ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 44d