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
158521–158544 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 1982
KM-KAL 4
K823020 · JIT
Kmn Products, Inc.
Chemistry · 34d
Cleared Nov 16, 1982
KM - KAL 5
K823021 · JIT
Kmn Products, Inc.
Chemistry · 34d
Cleared Nov 16, 1982
KM-KAL 6
K823022 · JIT
Kmn Products, Inc.
Chemistry · 34d
Cleared Nov 16, 1982
KM-KAL L6
K823023 · JIT
Kmn Products, Inc.
Chemistry · 34d
Cleared Nov 16, 1982
KM - KAL 1
K823024 · JIT
Kmn Products, Inc.
Chemistry · 34d
Cleared Nov 16, 1982
KM - KAL 2
K823025 · JIT
Kmn Products, Inc.
Chemistry · 34d
Cleared Nov 16, 1982
CIN AGAR MEDIUM
K823050 · JSJ
Gibco Laboratories Life Technologies,...
Microbiology · 29d
Cleared Nov 16, 1982
TRAVASORB NASOGASTRIC NASOINTESTINAL
K823082 · KNT
Travenol Laboratories, S.A.
Gastroenterology & Urology · 27d
Cleared Nov 16, 1982
CHANNEL BACK
K823093
J.G. Shuman Assoc.
Physical Medicine · 27d
Cleared Nov 16, 1982
RERMCO TEST CHLORIDE REAGENT
K823106 · JFS
Fermco Biochemics, Inc.
Chemistry · 26d
Cleared Nov 16, 1982
QUANTIMETRIC 2 CERULOPLASMIN ASSAY
K823107 · DDB
Kallestad Laboratories, Inc.
Immunology · 26d
Cleared Nov 16, 1982
QAP MICROCOMPUTER SYSTEM
K823110 · JQP
American Dade
Chemistry · 26d
Cleared Nov 16, 1982
BRACE-UP ALL PURPOSE WRIST BAND
K823113 · IQI
Arco Matic, Inc.
Physical Medicine · 26d
Cleared Nov 16, 1982
HITCH HIKER
K823117 · ITI
Amigo Sales, Inc.
Physical Medicine · 26d
Cleared Nov 16, 1982
MODEL SA-1 STETHOSCOPE AUDIO AMPLIFIER
K823126 · BZW
Electromedics, Inc.
Anesthesiology · 22d
Cleared Nov 16, 1982
ABDOMINAL BINDER
K823164 · KTD
Warm & Form, Orthopedic Materials
Physical Medicine · 22d
Cleared Nov 16, 1982
WRIST SPLING & FOREARM SPLINT
K823165 · ILH
Warm & Form, Orthopedic Materials
Physical Medicine · 22d
Cleared Nov 16, 1982
MICROSURGICAL INSTRUMENTS
K823174 · HNR
Concept, Inc.
Ophthalmic · 21d
Cleared Nov 16, 1982
SIDEWINDER OMNI WHEELCHAIR DIRECT/POWER
K823175 · ITI
Kinetic Concepts, Inc.
Physical Medicine · 21d
Cleared Nov 16, 1982
CHLAMYDIA TRANSETTEE 1 & 3
K823179 · JSM
Spectrum Co.
Microbiology · 21d
Cleared Nov 16, 1982
RAPID PRESUMPTIVE IDENT. GPA STREP
K823198 · JTO
Microchemical Specialities, Co.
Microbiology · 21d
Cleared Nov 16, 1982
DISPOSABLE DISPENSE MANIFOLD
K823218 · JTC
Dynatech Laboratories, Inc.
Microbiology · 19d
Cleared Nov 16, 1982
THERMAX
K823245 · KYA
American Thermometer Company, Inc.
Radiology · 15d
Cleared Nov 16, 1982
U-WAY QUICKOLLAR
K823247 · IQK
Ems Industries, Inc.
Physical Medicine · 15d