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
135529–135552 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 28, 1988
CHOLESTEROL
K880237 · CHH
Tech-Neal Scientific, Inc.
Chemistry · 99d
Cleared Apr 28, 1988
DESCENDING ARCH CANNULA
K880421 · DWF
Dlp, Inc.
Cardiovascular · 87d
Cleared Apr 28, 1988
SCIMED MODELS P-7-14 AND A-19-38 HEAT EXCHANGERS
K880451 · DTR
Scimed Life Systems, Inc.
Cardiovascular · 86d
Cleared Apr 28, 1988
PREGNANCY BETA-HCG CARD & LIQUID TEST
K880478 · JHJ
Ampcor, Inc.
Chemistry · 84d
Cleared Apr 28, 1988
MEDRAD MICROPROCESSOR CT INJECTION SYSTEM
K880493 · DXT
Medrad, Inc.
Cardiovascular · 83d
Cleared Apr 28, 1988
VACUGUARD(TM)
K880594 · JKA
Habley Medical Technology Corp.
Chemistry · 77d
Cleared Apr 28, 1988
CARBON DIOXIDE ASSAY KIT(ENZY. SINGLE) 203-10
K880866 · KHS
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 58d
Cleared Apr 28, 1988
MICRO CO2 APPARATUS
K880967 · CIE
Hf Scientific, Inc.
Chemistry · 51d
Cleared Apr 28, 1988
PARAMAX IRON REAGENT
K881104 · JIY
Baxter Healthcare Corp
Chemistry · 44d
Cleared Apr 28, 1988
ALLEGRO(TM) FOLLICLE STIMULATING HORMONE IMMUNO.
K881123 · CGJ
Nichols Institute Diagnostics
Chemistry · 43d
Cleared Apr 28, 1988
DIRECT BILIRUBIN PROCEDURE
K881166 · CIG
Data Medical Associates, Inc.
Chemistry · 41d
Cleared Apr 28, 1988
IRON PROCEDURE
K881167 · JIY
Data Medical Associates, Inc.
Chemistry · 41d
Cleared Apr 28, 1988
CARBON DIOXIDE REAGENT
K881169 · KHS
Intersect Systems, Inc.
Chemistry · 41d
Cleared Apr 28, 1988
PHOSPHORUS (INORGANIC)
K881171 · CEO
Tech-Co, Inc.
Chemistry · 38d
Cleared Apr 28, 1988
CHLORIDE LIQUID STABLE REAGENT SET
K881200 · CHJ
Medical Analysis Systems, Inc.
Chemistry · 38d
Cleared Apr 28, 1988
IRON TEST
K881202 · JIY
Sclavo, Inc.
Chemistry · 38d
Cleared Apr 28, 1988
ACP KINETIC TEST (ACID PHOSPHATASE TEST)
K881204 · CKB
Sclavo, Inc.
Chemistry · 38d
Cleared Apr 28, 1988
CREATINE KINASE (CK) REAGENT SET
K881237 · JHX
Tech-Neal Scientific, Inc.
Chemistry · 37d
Cleared Apr 28, 1988
CHLORIDE REAGENT SET
K881240 · CHJ
Tech-Neal Scientific, Inc.
Chemistry · 37d
Cleared Apr 28, 1988
DUODERM(R) HYDROACTIVE(R) PASTE
K881302 · FRO
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 31d
Cleared Apr 28, 1988
BIOTROL -GT GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST
K881311 · JQB
Biotrol, USA, Inc.
Chemistry · 31d
Cleared Apr 28, 1988
GAUZE AND LAP SPONGES -STERILE & NON-STERILE
K881395 · EFQ
A Plus International, Inc.
General & Plastic Surgery · 24d
Cleared Apr 28, 1988
CREATININE FOR CONTINUOUS FLOW INSTRUMENTS
K881400 · CGX
Catachem, Inc.
Chemistry · 24d
Cleared Apr 28, 1988
MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEM
K881439 · JXA
Los Alamos Diagnostics
Microbiology · 23d