FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
136273–136296 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 18, 1988
DNASE TEST AGAR
K881486 · JSH
Acumedia Manufacturers, Inc.
Microbiology · 10d
Cleared Apr 18, 1988
WESCOR GRAM STAIN PACK FOR MODEL 7300 AEROSPRAY
K881512 · JTS
Wescor, Inc.
Pathology · 7d
Cleared Apr 18, 1988
DEXTROSE AGAR
K881522 · JSG
Acumedia Manufacturers, Inc.
Microbiology · 10d
Cleared Apr 18, 1988
DEXTROSE TRYPTONE BROTH
K881523 · JSG
Acumedia Manufacturers, Inc.
Microbiology · 10d
Cleared Apr 18, 1988
DERMATOPHYTE TEST MEDIUM
K881524 · JSJ
Acumedia Manufacturers, Inc.
Microbiology · 10d
Cleared Apr 18, 1988
COOKED MEAT MEDIUM
K881525 · JSG
Acumedia Manufacturers, Inc.
Microbiology · 10d
Cleared Apr 18, 1988
CHAPMAN STONE MEDIUM
K881526 · JSJ
Acumedia Manufacturers, Inc.
Microbiology · 10d
Cleared Apr 18, 1988
CASMAN MEDIUM BASE
K881527 · JTY
Acumedia Manufacturers, Inc.
Microbiology · 10d
Cleared Apr 18, 1988
CASEIN PEPTONE, LOW VITAMIN
K881528 · JSG
Acumedia Manufacturers, Inc.
Microbiology · 10d
Cleared Apr 18, 1988
CARY AND BLAIR TRANSPORT MEDIUM
K881529 · JSM
Acumedia Manufacturers, Inc.
Microbiology · 10d