FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
123553–123576 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 14, 1991
DB 3000 A-SCAN SYSTEM
K904692 · IYO
Ocuserv Instruments, Inc.
Radiology · 90d
Cleared Jan 14, 1991
BC 1220 ANALOG - IMPLANT BODY
K904711 · DZE
Minimatic Implant Technology
Dental · 90d
Cleared Jan 14, 1991
CHLAMYDIA SYSTEM SOFTWARE (CSS)
K904725 · LJC
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 89d
Cleared Jan 14, 1991
ELIACHAR MODIFIED ESOPHAGEAL STENT
K904821 · ESW
Hood Laboratories
Gastroenterology & Urology · 82d
Cleared Jan 14, 1991
CT HILIGHT ADVANTAGE II
K904971 · JAK
GE Medical Systems
Radiology · 70d
Cleared Jan 14, 1991
THE BODY COOLER SYSTEM
K904998 · ILO
Costa / French
Physical Medicine · 69d
Cleared Jan 14, 1991
QUIDEL TOTAL IGE POSITIVE CONTROL SERUM
K905162 · DHB
Quidel Corp.
Immunology · 59d
Cleared Jan 14, 1991
PACSNET RESEARCH TOOLKIT
K905199 · LMD
Siemens Gammasonics, Inc.
Radiology · 55d
Cleared Jan 14, 1991
DALE VENTILATOR TUBING SUPPORT FOR TRACH. VENT.
K905231 · CBH
Dale Medical Products, Inc.
Anesthesiology · 55d
Cleared Jan 14, 1991
THE THERATEST ACA TEST
K905301 · GFO
Theratest Laboratories, Inc.
Immunology · 48d