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
170497–170520 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 10, 1978
PAPANICOLAOU STAIN :EA-50:
K781583 · HZJ
Bioscientific
Pathology · 22d
Cleared Oct 10, 1978
GRAM STAIN KIT
K781584 · HYI
Bioscientific
Pathology · 22d
Cleared Oct 10, 1978
HEMATOXYLIN STAIN HARRIS
K781585 · HYK
Bioscientific
Pathology · 22d
Cleared Oct 10, 1978
HEMATOLOGY STAIN PACK
K781587 · IAF
Bioscientific
Pathology · 22d
Cleared Oct 10, 1978
PAPANICOLAOU STIAN OG-6
K781588 · HZJ
Bioscientific
Pathology · 22d
Cleared Oct 10, 1978
TEKNI-CAL
K781601 · KRY
Streck Laboratories, Inc.
Chemistry · 22d
Cleared Oct 10, 1978
CDC ANAEROBE BLOOD W/KANAMYAN/VANCOM.
K781602 · JSJ
Anaerobe Systems
Microbiology · 22d
Cleared Oct 10, 1978
CDC ANAEROBE BLOOD AGAR W/PHENETHYLALCH.
K781603 · JSJ
Anaerobe Systems
Microbiology · 22d
Cleared Oct 10, 1978
CDC ANAEROBE BLOOD AGAR
K781604 · JSG
Anaerobe Systems
Microbiology · 22d
Cleared Oct 10, 1978
R&R ABSORBENT POINTS
K781605 · EKN
Ransom and Randolph
Dental · 22d
Cleared Oct 10, 1978
ECHO-OIL
K781631 · EMX
Echo Laboratories, Inc.
Radiology · 15d
Cleared Oct 10, 1978
RA-I
K781642 · IYN
Diasonics, Inc.
Radiology · 19d
Cleared Oct 10, 1978
HEARING AID, ITE MODULAR MODEL I, II, V
K781663 · ESD
Oticon Corp.
Ear, Nose, Throat · 12d
Cleared Oct 06, 1978
PRINTER, DIGITAL
K781115 · DSF
Output, Inc.
Cardiovascular · 95d
Cleared Oct 06, 1978
PREGELLED DISPOSABLE ELECTRODE
K781518 · DRX
Vente Medical Products, Inc.
Cardiovascular · 36d
Cleared Oct 06, 1978
MONITORING, PRESSURE KIT
K781680 · DRS
Pharmaseal Div., Baxter Healthcare Corp.
Cardiovascular · 4d
Cleared Oct 05, 1978
MODIFIED STERILE DISPOSABLE STOPCOCKS
K781579 · DTL
Cobe Laboratories, Inc.
Cardiovascular · 20d
Cleared Oct 04, 1978
PEEP/CPAP VALVE
K781332 · BYE
Vickers America Medical Corp.
Anesthesiology · 63d
Cleared Oct 03, 1978
ARCOBIOLITH PACEMAKER MODEL
K780776 · DXY
Arco Medical Products Co.
Cardiovascular · 148d
Cleared Oct 03, 1978
DEVIN-NESTOR PNEUMATIC TOURNIQUET
K780988 · KCY
Nestor Engineering Associates, Inc.
General & Plastic Surgery · 111d
Cleared Oct 03, 1978
DEVIN-NESTOR SQUARE KNIFE
K780989 · EMF
Nestor Engineering Associates, Inc.
General & Plastic Surgery · 111d
Cleared Oct 03, 1978
STAINLESS STEEL TEMPLATE
K780990
Nestor Engineering Associates, Inc.
General & Plastic Surgery · 111d
Cleared Oct 03, 1978
PARALLEL BLADE MARKER
K780991 · EMF
Nestor Engineering Associates, Inc.
General & Plastic Surgery · 111d
Cleared Oct 03, 1978
THC DIRECT RIA KIT
K781048 · LAT
Immunalysis Corporation
Toxicology · 104d