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
169609–169632 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 20, 1979
MICROLITH MODELS 505
K790432 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 18d
Cleared Mar 19, 1979
AUTOSAMPLER, MODEL AS-40
K790117 · JXR
The Perkin-Elmer Corp.
Toxicology · 55d
Cleared Mar 19, 1979
ELECTROAPPLICATOR MODEL C-1
K790205 · KTB
Mcg, Inc.
Physical Medicine · 47d
Cleared Mar 19, 1979
MODIFIED JACKSON-REES CIRCUIT
K790214 · CAI
Vital Signs, Inc.
Anesthesiology · 48d
Cleared Mar 19, 1979
EMIT AUTO DIGOXIN ASSAY
K790303 · KXT
Syva Co.
Toxicology · 34d
Cleared Mar 19, 1979
MODEL 337E HEARING AID
K790412 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 21d
Cleared Mar 19, 1979
IMPLANTABLE HEART LEAD EXTENDER
K790468 · DTD
Arco Medical Products Co.
Cardiovascular · 14d
Cleared Mar 19, 1979
PACEMAKER, OVALITH-D CARDIAC
K790566 · DXY
Caratomic
Cardiovascular
Cleared Mar 16, 1979
TELEMETRY, BIOMEDICAL
K790109 · DRG
Lkc Technologies, Inc.
Cardiovascular · 58d
Cleared Mar 16, 1979
BREATHING CIRCUIT, DISPOSABLE
K790115 · CAI
H.B. Laboratories, Inc.
Anesthesiology · 53d
Cleared Mar 16, 1979
OXYGEN MASK, ADULT VINYL
K790166 · BYG
Airlife, Inc.
Anesthesiology · 63d
Cleared Mar 16, 1979
QUICK-CHECK
K790277 · DXN
United States Surgical, A Division of...
Cardiovascular · 36d
Cleared Mar 16, 1979
HEIFETZ ANEURYSM CLIP, LMM BLADE
K790413 · HCH
Edward Weck, Inc.
Neurology · 18d
Cleared Mar 16, 1979
THE GUARDIAN SPHYGMOMANOMETER
K790470 · DXN
World Book Encyclopedia, Inc.
Cardiovascular · 11d
Cleared Mar 15, 1979
PROACTIVATOR C3, C4 AND C3
K790059 · KTP
Icl Scientific
Immunology · 65d
Cleared Mar 15, 1979
IIF-A-N-DNA TEST KIT
K790106 · DHC
Medica Corp.
Immunology · 56d
Cleared Mar 15, 1979
DEHYDROGENOSE, GLUCOSE PHOSPHATE
K790211 · JBL
Sigma Chemical Co.
Chemistry · 43d
Cleared Mar 15, 1979
SPECTROPHOTOMETER MODEL 3000
K790235 · KHO
The Perkin-Elmer Corp.
Chemistry · 42d
Cleared Mar 15, 1979
SPECTROPHOTOMETER MODEL 650-40
K790236 · KHO
The Perkin-Elmer Corp.
Chemistry · 42d
Cleared Mar 15, 1979
ANTI-NATIVE DEOXYRIB-ONUCLEIC ACID ANTI
K790252 · DHN
Meloy Laboratories, Inc.
Immunology · 37d
Cleared Mar 15, 1979
SYSTEMIC LUPUS
K790257 · DHC
Icl Scientific
Immunology · 37d
Cleared Mar 15, 1979
CALBIOCHEM-BEHRING LASER IMMUNOGLOBULIN
K790330 · JJY
Calbiochem-Behring Corp.
Immunology · 27d
Cleared Mar 15, 1979
RHEUMATELL
K790351 · DHR
Central Biological Co.
Immunology · 21d
Cleared Mar 15, 1979
TRYPTIC SOY AGAR W/ 5% HORSE BLOOD
K790375 · JSG
Granite Diagnostics, Inc.
Immunology · 20d