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
169345–169368 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 01, 1979
BEHIND-THE-EAR HEARING INSTRUMENT, H56
K790700 · ESD
Marcon Hearing Instruments, Inc.
Ear, Nose, Throat · 19d
Cleared May 01, 1979
BEHIND-THE-EAR HEARING INSTRUMENT, H54
K790726 · ESD
Marcon Hearing Instruments, Inc.
Ear, Nose, Throat · 18d
Cleared May 01, 1979
BEHIND-THE-EAR, MODEL H37D
K790727 · ESD
Marcon Hearing Instruments, Inc.
Ear, Nose, Throat · 18d
Cleared May 01, 1979
OCTAGONAL ALUMINUM FRAMING SYSTEM
K790729 · HST
Orthopedic Systems, Inc.
Neurology · 19d
Cleared May 01, 1979
_MODEL WC-1 BEHIND-THE-EAR HEARING AID
K790745 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 15d
Cleared May 01, 1979
ESSAR TOURNIQUET FOR VENIPUNCTURE
K790802 · GAX
Stewart Research, Inc.
General & Plastic Surgery · 6d
Cleared Apr 30, 1979
BIOSTIL # 3884
K790077 · FPA
Venospital, Inc.
General Hospital · 109d
Cleared Apr 30, 1979
T-CONNECTOR
K790408 · FPA
Medex, Inc.
General Hospital · 63d
Cleared Apr 30, 1979
FLU-VEN 01510
K790424 · FPA
Venospital, Inc.
General Hospital · 60d
Cleared Apr 30, 1979
JELCO* DISC FILTER-0.2 MICRON
K790471 · FPB
Jelco Laboratories
General Hospital · 56d
Cleared Apr 30, 1979
EPIC D215
K790574 · FPA
National Patent Development Corp.
General Hospital · 38d
Cleared Apr 30, 1979
INFANT SCALE DISPOSABLE LINER
K790659 · KME
Hydro-Med Products, Inc.
General Hospital · 26d
Cleared Apr 30, 1979
KETAC APPLIC-CAPSULES
K790832 · EMA
Espe GmbH (Us)
Dental
Cleared Apr 30, 1979
VISIO-BOND
K790833 · KLE
Espe GmbH (Us)
Dental
Cleared Apr 27, 1979
LUNG FUNCTION AMPLIFIER EXERCISER
K790744 · BWF
Empire Plastics Manufacturer
Anesthesiology · 11d
Cleared Apr 27, 1979
MODEL M25R, OXYGEN ANALYZER
K790784 · CCL
Catalyst Research Corp.
Anesthesiology · 4d
Cleared Apr 27, 1979
MODEL M25RL, (CRC) OXYGEN ANALYZER
K790785 · CCL
Catalyst Research Corp.
Anesthesiology · 4d
Cleared Apr 26, 1979
DETECTION SYSTEM, MS-2 ELECTROCHEMICAL
K790297 · JTA
Abbott Laboratories
Microbiology · 76d
Cleared Apr 26, 1979
TY RIA KIT, AUTOMATED ASSAY SYSTEM
K790477 · CDX
E. R. Squibb & Sons, Inc.
Chemistry · 48d
Cleared Apr 26, 1979
ANUS STIMULATOR
K790531 · ILS
Maddak, Inc.
Physical Medicine · 42d
Cleared Apr 26, 1979
SUBMAX
K790644 · DRT
Chase Mfg. Co.
Cardiovascular · 27d
Cleared Apr 26, 1979
CLOSED WOUND VACUUM DRAINAGE SYSTEM
K790654 · GCY
3M Company
General & Plastic Surgery · 21d
Cleared Apr 26, 1979
NDM PAPER TAPE ECG ELECTRODE
K790730 · DRX
Ndm Corp.
Cardiovascular · 13d
Cleared Apr 26, 1979
EMIT-TOX SERUM BENZODIAZEPINE ASSAY
K790736 · JXM
Syva Co.
Toxicology · 10d