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
167113–167136 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 10, 1980
ESOPHAGEAL STETHESCOPE
K800463 · BZW
Medical Components, Inc.
Anesthesiology · 10d
Cleared Mar 07, 1980
FETAL MONITOR MODEL FHM-1
K800013 · HGM
Advantage Medical Systems, Inc.
Obstetrics & Gynecology · 63d
Cleared Mar 05, 1980
FIXOMULL
K792725 · FPX
Beiersdorf, Inc.
General & Plastic Surgery · 65d
Cleared Mar 05, 1980
ECG MONITOR OSCILLOSCOPE MODEL OEC-3200
K800004 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 63d
Cleared Mar 05, 1980
ECG MONITOR OSCILLOSCOPE MODEL OEC-3100
K800005 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 63d
Cleared Mar 05, 1980
SIEMENS-ELEMA AB MANUAL VENTILATION
K800114 · CBK
Siemens Elema AB
Anesthesiology · 48d
Cleared Mar 05, 1980
DATA MANAGEMENT SYSTEM IL MODEL 775
K800282 · JQP
Instrumentation Laboratory CO
Chemistry · 26d
Cleared Mar 05, 1980
WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3
K800296 · GGM
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 23d
Cleared Mar 05, 1980
SANDARE FAST 340 PHOSPHOROUS PROCEDURE
K800297 · CEO
Sandare Chemical Co., Inc.
Chemistry · 23d
Cleared Mar 05, 1980
AMERLEX T-4 RIA KIT
K800300 · CDX
Amersham Corp.
Chemistry · 23d
Cleared Mar 05, 1980
SIGMA PROCEDURE & REAGENT SYSTEM #335-UV
K800301 · CDT
Sigma Chemical Co.
Chemistry · 23d
Cleared Mar 05, 1980
ORTHO ANTISERA CONTROL
K800310 · KSF
Ortho Diagnostics, Inc.
Hematology · 22d
Cleared Mar 05, 1980
SURGITEK FOERSTER FACE LIFT DRAIN
K800331 · GCY
Medical Engineering Corp.
General & Plastic Surgery · 21d
Cleared Mar 05, 1980
RADIOEAR MODEL 2080 (HEARING AID)
K800332 · ESD
Radioear Corp.
Ear, Nose, Throat · 20d
Cleared Mar 05, 1980
GOLDEN RETRIEVERS OR SILVER RETRIEVERS
K800444 · HXB
Instrument Makar, Inc.
Orthopedic · 6d
Cleared Mar 05, 1980
WATER PIK TRAVELER, MODEL 79
K800448 · EFS
Teledyne, Inc.
Dental · 6d
Cleared Mar 04, 1980
GRAPHIC STRESS TELETHERMOMETRY
K800491 · IYM
Gst Laboratories of Ca, Inc.
Radiology
Cleared Mar 03, 1980
HYSTEROSER
K791330 · HIH
A. B. Vacuum Extractor, Inc.
Obstetrics & Gynecology · 229d
Cleared Mar 03, 1980
BIOFEEDBACK DEVICES & ACCESSORIES
K792115 · HCC
M.O.E Electronics Research & Prod.
Neurology · 145d
Cleared Mar 03, 1980
FIAX TEST KIT FOR HERPES SIMPLEX VIRUS
K792559 · GQL
Intl. Diagnostic Technology
Chemistry · 83d
Cleared Mar 03, 1980
XR-710
K800063 · EAP
Pennwalt Corp.
Radiology · 52d
Cleared Mar 03, 1980
CRAWFORD LACRIMAL INTUBATION SET
K800089 · HNL
Jedmed Instrument Co.
Ophthalmic · 49d
Cleared Mar 03, 1980
PANOREX II DENTAL X-RAY UNIT
K800133 · EHD
Pennwalt Corp.
Radiology · 42d
Cleared Mar 03, 1980
SILASTIC SCLERAL SPONGE II W/CIRCLING BD
K800140 · HQX
Dow Corning Corp. Healthcare...
Ophthalmic · 42d