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
122953–122976 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 15, 1991
HEWLETT PACKARD MODEL 5650C, CARDIO DATA MGMT SYST
K905100 · DQK
Hewlett-Packard Co.
Cardiovascular · 63d
Cleared Jan 15, 1991
DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD.
K905311 · DWD
Baxter Bentley Laboratories, Inc.
Cardiovascular · 48d
Cleared Jan 15, 1991
DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELS
K905312 · DWF
Baxter Bentley Laboratories, Inc.
Cardiovascular · 48d
Cleared Jan 15, 1991
VARIOUS
K905319 · EJT
Ivoclar North America, Inc.
Dental · 48d
Cleared Jan 15, 1991
DEGUDENT GS
K905387 · EJT
Degussa AG
Dental · 46d
Cleared Jan 15, 1991
GLYC-AFFIN(TM)-GA
K905513 · LCP
Isolab, Inc.
Chemistry · 36d
Cleared Jan 15, 1991
CIBA CORNING ACS T4 IMMUNOASSAY
K905532 · CDX
Ciba Corning Diagnostics Corp.
Chemistry · 36d
Cleared Jan 15, 1991
PATIENT EXAMINATION GLOVES
K905551 · LYY
Johnson & Johnson Medical, Inc.
General Hospital · 35d
Cleared Jan 15, 1991
TECHLYTE ELECTROLYTE ANALYZER
K905600 · JGS
Technalysis, Inc.
Chemistry · 32d
Cleared Jan 15, 1991
SYSTEMATE CALCIUM (EPOS APPLICATION) #65409
K905659 · CIC
Em Diagnostic Systems, Inc.
Chemistry · 29d
Cleared Jan 15, 1991
PATIENT EXAMINATION GLOVES
K905665 · LYY
Medical Products Search, Inc.
General Hospital · 28d
Cleared Jan 15, 1991
EZ-SCREEN: AMPHETAMINES
K905700 · DKZ
Environmental Diagnostics, Inc.
Toxicology · 26d
Cleared Jan 15, 1991
ABUSCREEN ONTRAK FOR COCAINE (200NG/ML)
K905730 · KLN
Roche Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Jan 15, 1991
PATIENT EXAMINATION GLOVES-POWDER FREED
K910045 · LYY
Pan-Century Rubber Products Sdn. Bhd.
General Hospital · 11d
Cleared Jan 15, 1991
PATIENT EXAMINATION GLOVES-ANATOMICAL GLOVES
K910046 · LYY
Pan-Century Rubber Products Sdn. Bhd.
General Hospital · 11d
Cleared Jan 15, 1991
PATIENT EXAMINATION GLOVES-TEXTURED GLOVES
K910047 · LYY
Pan-Century Rubber Products Sdn. Bhd.
General Hospital · 11d
Cleared Jan 14, 1991
BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS
K901548 · CCC
Shiley, Inc.
Anesthesiology · 286d
Cleared Jan 14, 1991
CLINI-CALC
K903135 · BSZ
Shasta Logic Corp.
Anesthesiology · 181d
Cleared Jan 14, 1991
DEFEND LATEX EXAM. GLOVES(AMBIDEXT/NON-STER/HYPOAL
K903439 · LYY
Glovco Malaysia Sdn Bhd
General Hospital · 175d
Cleared Jan 14, 1991
SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER
K903448 · LCJ
Medical Engineering Corp.
General & Plastic Surgery · 167d
Cleared Jan 14, 1991
AMICI XENON ADMINISTRATION SET
K903805 · IYT
Amici, Inc.
Radiology · 152d
Cleared Jan 14, 1991
DCW MODULAR PROXIMAL FEMORAL SYSTEM
K904028 · LZO
Dow Corning Wright
Orthopedic · 136d
Cleared Jan 14, 1991
RICH-MAR MODEL V ULTRASOUND
K904051 · IMI
Rich-Mar Corp.
Physical Medicine · 132d
Cleared Jan 14, 1991
AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION
K904684 · IYT
Amici, Inc.
Radiology · 152d