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
164521–164544 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 1981
GAMMA STICK 125-1 TOBRAMYCIN RIA KIT
K810011 · KLB
Alpha Gamma Laboratory
Toxicology · 23d
Cleared Jan 28, 1981
DENTAL ENDODONTIC CEMENT
K810026 · EMA
Witech Laboratory
Dental · 23d
Cleared Jan 28, 1981
MIC-2000 INOCULUM TRAY LID
K810039 · JTC
Dynatech Corp.
Microbiology · 19d
Cleared Jan 28, 1981
BACTEC BACTERIAL DETECTION SYSTEM: #5
K810042 · JTA
Bd Becton Dickinson Vacutainer...
Microbiology · 21d
Cleared Jan 28, 1981
JOHNSON & JOHNSON ADHESIVE FILM DRESSING
K810053 · KGX
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 16d
Cleared Jan 28, 1981
RICA (DIAGNOSTIC INSTRUMENTS)
K810054 · GWZ
Robert I. Chien & Assoc., Inc.
Neurology · 16d
Cleared Jan 28, 1981
SCOTT CM42 PASTEURIZER
K810065 · HGX
William Harvey Life Products Corp.
Obstetrics & Gynecology · 15d
Cleared Jan 28, 1981
OMEGA THERAPEUTIC DRUG MONIT. CONTROL S.
K810077 · DIF
Hyland Therapeutic Div., Travenol...
Chemistry · 15d
Cleared Jan 28, 1981
LDH-L LIQUID ENZYMATIC, KINETIC KIT
K810083 · CFJ
Bio-Analytics Laboratories, Inc.
Chemistry · 15d
Cleared Jan 28, 1981
IRON KIT
K810085 · CFM
Bio-Analytics Laboratories, Inc.
Chemistry · 15d
Cleared Jan 28, 1981
IRON & TICB
K810086 · JQF
Bio-Analytics Laboratories, Inc.
Chemistry · 15d
Cleared Jan 28, 1981
URIC ACID (TPTZ) COLORINMETRIC
K810088 · CDH
Bio-Analytics Laboratories, Inc.
Chemistry · 15d
Cleared Jan 28, 1981
MODEL 2 FLOWMETER
K810132 · CAN
Harris Calorific
Anesthesiology · 9d
Cleared Jan 28, 1981
TAMPAX MAXITHINS PADS
K810160 · HHD
Tampax, Inc.
Obstetrics & Gynecology · 6d
Cleared Jan 26, 1981
DEPILATOR, DERMA-I & DERMA-II
K770791 · KCX
Electro-Kinetic Eng/Mfg
General & Plastic Surgery · 1365d
Cleared Jan 26, 1981
AMES SERA-PAK HEMOGLOBIN REAGENT
K803248 · KHG
Miles Laboratories, Inc.
Hematology · 34d
Cleared Jan 26, 1981
AIP SYSTEM-METHOD FOR IGM
K803251 · DFT
Icl Scientific
Immunology · 34d
Cleared Jan 26, 1981
AUTOMATED IMMUNOPRECIPITIN METHOD/ICG
K803272 · DFZ
Icl Scientific
Immunology · 28d
Cleared Jan 26, 1981
AUTOMATED IMMUNOPRECIPITIN METHOD/IGA
K803274 · CZP
Icl Scientific
Immunology · 28d
Cleared Jan 26, 1981
ANA-IFA TEST SYSTEM
K803276 · DHN
Immuno Concepts, Inc.
Immunology · 28d
Cleared Jan 26, 1981
STERILE DISPOSABLE INSTRUMENT TRAYS
K810004 · FSM
Ascep, Inc.
General & Plastic Surgery · 20d
Cleared Jan 26, 1981
SRD III
K810022 · JTC
Dynatech Corp.
Chemistry · 21d
Cleared Jan 26, 1981
BI-CENTRIC BI-POLAR ENDOPROSTHESIS
K810062 · KWY
Howmedica Corp.
Orthopedic · 13d
Cleared Jan 26, 1981
AUTOMATIC BIOCHEMICAL ANALYZER
K810063 · JQP
Acculab
Chemistry · 13d