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
168793–168816 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 03, 1979
ANTISERUM TO HUMAN ALPHA-2-MACROBLOBULIN
K790710 · DDY
Kent Laboratories, Inc.
Immunology · 113d
Cleared Aug 03, 1979
ANTISERUM TO HUMAN C-REACTIVE PROTEINS
K790716 · DCN
Kent Laboratories, Inc.
Immunology · 113d
Cleared Aug 03, 1979
LODA WRIST PROSTHESIS
K790774 · KWM
Depuy, Inc.
Orthopedic · 105d
Cleared Aug 03, 1979
PORCELIT
K790806 · EBA
Harry J. Bosworth Co.
Dental · 101d
Cleared Aug 03, 1979
METALIT
K790807 · EBA
Harry J. Bosworth Co.
Dental · 101d
Cleared Aug 03, 1979
SUBCUTANEOUS TISSUE EXPANDER
K790842 · LCJ
Heyer Schulte Corp.
General & Plastic Surgery · 93d
Cleared Aug 03, 1979
SURGICAL DRAPE CLIP #201
K790855 · GDO
C. Intl.
General & Plastic Surgery · 91d
Cleared Aug 03, 1979
SCREENING AUDIOMETER, HIGH FREQUENCY
K790878 · EWO
Vicon Instrument Co.
Ear, Nose, Throat · 88d
Cleared Aug 03, 1979
OPHTHALMIC DRESSING TRAY
K790909 · HOX
Pent-Cal, Inc.
Ophthalmic · 81d
Cleared Aug 03, 1979
INTRACRANIAL PRESSURE MONITORING
K790920 · GWM
Codman & Shurtleff, Inc.
Neurology · 86d
Cleared Aug 03, 1979
DELTON* PIT AND FISSURE SEALENT
K790935 · EBC
Johnson & Johnson Professionals, Inc.
Dental · 79d
Cleared Aug 03, 1979
S/A 7800 BIRTH SUPPORT CHAIR
K790950 · KNC
Schlosser Alberti Co.
Obstetrics & Gynecology · 74d
Cleared Aug 03, 1979
SA/7860 FETAL HEART MONITOR (DOPPLER)
K790951 · KNG
Schlosser Alberti Co.
Obstetrics & Gynecology · 74d
Cleared Aug 03, 1979
STAT DIFF STAIN
K791007 · KQC
Bioscientific
Hematology · 64d
Cleared Aug 03, 1979
ECA (SPECIAL) HEME BUFFER
K791008 · JBD
Electrophoresis Corp. of America
Hematology · 64d
Cleared Aug 03, 1979
MCSPADDEN CONDENSOR
K791019 · EKR
Techdent, Inc.
Dental · 63d
Cleared Aug 03, 1979
ENDOSCOPIC INSTRUMENT
K791052 · HET
Eder Instrument Co, Inc.
Obstetrics & Gynecology · 58d
Cleared Aug 03, 1979
H-H SLOTTED CATHETER-RESERVOIR
K791075 · JXG
Holter-Hausner Intl.
Neurology · 52d
Cleared Aug 03, 1979
H-H SLOTTED VENTRICULAR CATHETER
K791076 · JXG
Holter-Hausner Intl.
Neurology · 52d
Cleared Aug 03, 1979
RADIOIMMUNOASSAY TEST SYSTEM
K791096 · JMG
Corning Medical & Scientific
Immunology · 52d
Cleared Aug 03, 1979
CEPTORTRODE WITH CEPTOR HESIVE
K791097 · GXY
Med General
Neurology · 52d
Cleared Aug 03, 1979
KINETIC DETERMINATION OF UV GLUCOSE
K791110 · LFR
The Dow Chemical Co.
Chemistry · 50d
Cleared Aug 03, 1979
GOAR ANTI-HUMAN LAMBODA CHAIN
K791115 · DEH
Protos Laboratories
Toxicology · 49d
Cleared Aug 03, 1979
RABBIT COMPLEMENT
K791117 · KTQ
Calbiochem-Behring Corp.
Hematology · 49d