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
142633–142656 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 27, 1986
EMPI, MODEL 1000 HAND HELD ELECTRODE
K862231 · GXY
Empi
Neurology · 77d
Cleared Aug 27, 1986
ANAEROBE RAPID CHROMOGENIC ID PANEL
K862332 · JSP
American Micro Scan
Microbiology · 69d
Cleared Aug 27, 1986
EXEL BUTTERFLY SCALP VEIN SET
K862491 · FPA
Exel Intl.
General Hospital · 57d
Cleared Aug 27, 1986
CADD-1, MODEL 5100 HF
K862927 · FRN
Deltec Systems, Inc.
General Hospital · 26d
Cleared Aug 27, 1986
PHASE II FERRITIN RADIOIMMUNOASSAY KIT
K862960 · DBF
Medical & Scientific Designs, Inc.
Immunology · 22d
Cleared Aug 27, 1986
AGAR REDUCTION IN FORMULA FOR PDC 110 & 310 MEDIA
K863164 · JSM
Precision Dynamics Corp.
Microbiology · 9d
Cleared Aug 27, 1986
KIMLON DISPOSABLE BLANKET
K863179 · KME
Kimberly-Clark Corp.
General Hospital · 9d
Cleared Aug 26, 1986
BUNN MODEL 22 OXYGEN FLOW CONTROLLER
K861199 · NFB
The John Bunn Co.
Anesthesiology · 148d
Cleared Aug 26, 1986
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (MG)
K861386 · JGJ
Eastman Kodak Company
Chemistry · 134d
Cleared Aug 26, 1986
ELECTROPHORESIS WORK CENTER (EWC)
K861414 · JJN
Helena Laboratories
Chemistry · 133d
Cleared Aug 26, 1986
PC-PLAN
K862065 · IYE
Dosimetrix, Inc.
Radiology · 88d
Cleared Aug 26, 1986
VISIBLE-CHLAMYDIA(TM) TEST SYSTEM
K862638 · LJC
Isolab, Inc.
Microbiology · 47d
Cleared Aug 26, 1986
PALLADIUM BASED DENT ALLOYS/PORCELAIN METAL RESTOR
K862856 · EJS
Austenal Dental, Inc.
Dental · 28d
Cleared Aug 26, 1986
OTICON I31 CITE HEARING AID
K862980 · ESD
Oticon Corp.
Ear, Nose, Throat · 19d
Cleared Aug 26, 1986
PULMANEX TM (MODIFICATION)
K863026 · BTM
Life Design Systems, Inc.
Anesthesiology · 15d
Cleared Aug 26, 1986
CB BUR
K863097 · EJL
Beavers Dental, Div. Sybron Canada, Ltd.
Dental · 12d
Cleared Aug 26, 1986
PIK POCKET (IRRIGATING TIP)
K863131 · EFS
Teledyne, Inc.
Dental · 11d
Cleared Aug 26, 1986
KULZER GLASS IONOMER LINER
K863141 · EMA
Shofu Dental Corp.
Dental · 11d
Cleared Aug 26, 1986
BUN (RATE) REAGENT
K863196 · CDQ
Sigma Diagnostics, Inc.
Chemistry · 7d
Cleared Aug 25, 1986
ACCULEVEL PHENOBARBITAL TEST
K854607 · DLZ
Syva Co.
Toxicology · 280d
Cleared Aug 25, 1986
ACCULEVEL PHENYTOIN TEST
K855026 · DIP
Syva / A Syntex Co.
Toxicology · 252d
Cleared Aug 25, 1986
PHD-36 PHYSIOLOGICAL SIGNAL AMPLIFIER
K860289 · GWL
Professional Health Technologies, Inc.
Neurology · 209d
Cleared Aug 25, 1986
OSCILLOMATE BLOOD PRESSURE MONITOR-MODEL 915
K860488 · DXN
Cas Medical Systems, Inc.
Cardiovascular · 196d
Cleared Aug 25, 1986
CIRCADIAN STRESS TEST SYSTEM
K860973 · DPS
Circadian, Inc.
Cardiovascular · 164d