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
153721–153744 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 05, 1984
APPOSE DISPOS. SKIN STAPLER W/AUTO
K840178 · GAG
Davis & Geck, Inc.
General & Plastic Surgery · 48d
Cleared Mar 05, 1984
VOFLEX
K840239 · BWF
Dhd Medical Products Div. Diemolding...
Anesthesiology · 45d
Cleared Mar 05, 1984
LYSE-TEC
K840289 · GGK
Medilab Corp.
Hematology · 41d
Cleared Mar 05, 1984
CAT. 4-OBSTETRICS GYNECOLOGY DEV'S
K840308 · KOH
Imm Enterprises , Ltd.
Obstetrics & Gynecology · 41d
Cleared Mar 05, 1984
INFA COMPLETE BREAST PUMP & MILK STORAG
K840325 · HGY
Monterey Laboratories, Inc.
Obstetrics & Gynecology · 40d
Cleared Mar 05, 1984
CEMENT RESTRICTOR
K840413 · JDK
American Ortomed Corp.
Orthopedic · 34d
Cleared Mar 05, 1984
HEMOCATH REPAIR KIT
K840424 · KNZ
Quinton, Inc.
Gastroenterology & Urology · 33d
Cleared Mar 05, 1984
UNITIZED HEMATOLOGY SET 65132/93
K840477 · GIF
Emd Chemicals, Inc.
Hematology · 31d
Cleared Mar 05, 1984
DISPOSABLE SYRINGE FILTERS
K840556 · KET
Corning Medical & Scientific
Pathology · 26d
Cleared Mar 05, 1984
LF MOTORIZED RADIOGRAPHIC FILM VIEWER
K840607 · IXC
Sybron Corp.
Radiology · 21d
Cleared Mar 05, 1984
MUSCLE STIMULATOR X-10
K840724 · IPF
Biostim, Inc.
Physical Medicine · 13d
Cleared Mar 05, 1984
PULMONARY FUNCTION TESTING STS
K840741 · BZG
Circadian, Inc.
Anesthesiology · 33d
Cleared Mar 02, 1984
OPTI-BEAM IV
K832919 · EAZ
Dentsply Intl.
Dental · 190d
Cleared Mar 02, 1984
BDH BIPOLAR FEMORAL COMPONENT A3
K833404 · KWY
Carbomedics, Inc.
Orthopedic · 154d
Cleared Mar 02, 1984
POROCOAT NEB TOTAL HIP SYSTEM
K833439 · LPH
Depuy, Inc.
Orthopedic · 149d
Cleared Mar 02, 1984
DISPOS. ENTERIC FEEDING TUBES W/SAFE-T
K833687 · KNT
Superior Plastic Products Corp.
Gastroenterology & Urology · 123d
Cleared Mar 02, 1984
TEXAS BIO SCAN
K833694 · HKI
Texas Bio Scan
Ophthalmic · 136d
Cleared Mar 02, 1984
SILVERAK
K833838 · LCN
Anil S. Gautam
Dental · 120d
Cleared Mar 02, 1984
SYSMEX CC-780 EIGHT PARAMETER AUT0
K834021
Toa Medical Electronics USA, Inc.
Hematology · 101d
Cleared Mar 02, 1984
ADP IFA TEST FOR CHLAMYDIAE TRACHOMATIS
K834242 · LJP
Apple Diagnostic Products
Immunology · 87d
Cleared Mar 02, 1984
DAT TEST FOR CHAGAS' DISEASE
K834328 · GNE
Sero-Immuno Diagnostics, Inc.
Immunology · 84d
Cleared Mar 02, 1984
ALDOSTERONE RADIOIMMUNOASSAY TEST KIT
K834428 · CJM
Serono Laboratories, Inc.
Chemistry · 78d
Cleared Mar 02, 1984
LIQUID STABLE TRIGLYCERIDES REAGENT SET
K834518 · CDT
Medical Analysis Systems, Inc.
Chemistry · 72d
Cleared Mar 02, 1984
DISCS
K840028 · JTO
Anaerobe Systems
Microbiology · 57d