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
135673–135696 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 18, 1988
ILLUMINA 55 CO2 LASER SYSTEM
K880429 · EWG
Cooper Lasersonics, Inc.
Ear, Nose, Throat · 77d
Cleared Apr 18, 1988
INTERCEPT T.E.N.S. DEVICE
K880492 · GZJ
Medical Design & Manufacturing Corp.
Neurology · 74d
Cleared Apr 18, 1988
DEXPAD, BLOOD GLUCOSE STRIP
K880585 · CGA
Mach Diag. C/O Wichita State University
Chemistry · 68d
Cleared Apr 18, 1988
EMIT T-UPTAKE ASSAY THYROID HORMONE BINDING RATIO
K880619 · KHQ
Syva Co.
Chemistry · 62d
Cleared Apr 18, 1988
CAPCADDY
K880621 · EJI
Capcad, Inc.
Dental · 62d
Cleared Apr 18, 1988
LABCO LIMITED EXETAINER(R)
K880622 · JKA
Labco, Ltd.
Chemistry · 62d
Cleared Apr 18, 1988
SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY
K880758 · CEP
Boots-Celltech Diagnostics, Inc.
Chemistry · 53d
Cleared Apr 18, 1988
G-CERA PORCELAIN BOND
K880765 · EBF
G-C Intl. Corp.
Dental · 52d
Cleared Apr 18, 1988
PORCELAIN PRIMER
K880790 · DYH
Reliance Orthodontic Products, Inc.
Dental · 52d
Cleared Apr 18, 1988
PLASTIC PRIMER
K880792 · DYH
Reliance Orthodontic Products, Inc.
Dental · 52d
Cleared Apr 18, 1988
RESUBMITTED BICARBONATE (CO2) REAGENT SINGLE VIAL
K880794 · KHS
Trace America, Inc.
Chemistry · 52d
Cleared Apr 18, 1988
RESUBMITTED ALKALINE PHOSPHATASE REAGENT AMP BUFF.
K880795 · CJE
Trace America, Inc.
Chemistry · 52d
Cleared Apr 18, 1988
ALKALINE PHOSPHATASE REAGENT, DEA BUFF
K880796 · CJE
Trace America, Inc.
Chemistry · 52d
Cleared Apr 18, 1988
ACID PHOSPHATASE REAGENT
K880798 · CKB
Trace America, Inc.
Chemistry · 52d
Cleared Apr 18, 1988
ILLUMINA MODEL 25 CO2 LASER FOR GENERAL/PLASTIC SU
K880807 · GEX
Cooper Lasersonics, Inc.
General & Plastic Surgery · 52d
Cleared Apr 18, 1988
ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SU
K880808 · GEX
Cooper Lasersonics, Inc.
General & Plastic Surgery · 52d
Cleared Apr 18, 1988
ILLUMINA MODEL 55 CO2 LASER FOR GENERAL/PLASTIC SU
K880809 · GEX
Cooper Lasersonics, Inc.
General & Plastic Surgery · 52d
Cleared Apr 18, 1988
MODIFIED AMERLEX-M PROGESTERONE RADIOIMMUNO. KIT
K880934 · JLS
Amersham Corp.
Chemistry · 42d
Cleared Apr 18, 1988
CALCIUM, CATALOGUE NUMBER 122-20
K881054 · CIC
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 38d
Cleared Apr 18, 1988
ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY
K881124 · CEP
Nichols Institute Diagnostics
Chemistry · 33d
Cleared Apr 18, 1988
RAJAH
K881354 · EJT
J.F. Jelenko & Co., Inc.
Dental · 19d
Cleared Apr 18, 1988
CELL-CULTURE SHAKER
K881466 · KJB
Cryodyne Technologies, Inc.
Pathology · 12d
Cleared Apr 18, 1988
MICROSCOPE STAGE HEATER
K881467 · KEJ
Cryodyne Technologies, Inc.
Pathology · 12d
Cleared Apr 18, 1988
HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTED
K881477 · KEL
Stat Path
Pathology · 11d