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
137689–137712 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 04, 1987
EPICARIDA, LE
K872837 · DSI
Medicomp, Inc.
Cardiovascular · 107d
Cleared Nov 04, 1987
STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(597 ADHE)
K872869 · DXH
Labeltape Meditect, Inc.
Cardiovascular · 106d
Cleared Nov 04, 1987
AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT
K873064 · DHR
Amtec Diagnostics International, Inc.
Immunology · 91d
Cleared Nov 04, 1987
DYNABEADS HLA CELL PREP II ISOLATION PRODUCT
K873185 · JCF
Dynal Biotech, Inc.
Hematology · 84d
Cleared Nov 04, 1987
ECG BASED MEDIA
K873267 · KZI
Central Media
Microbiology · 85d
Cleared Nov 04, 1987
MUELLER HINTON MEDIA
K873268 · JTZ
Central Media
Microbiology · 85d
Cleared Nov 04, 1987
MYCOLOGICAL MEDIA
K873269 · JSI
Central Media
Microbiology · 85d
Cleared Nov 04, 1987
ACTINOMYCETE DIFFERENTIAL MEDIA
K873270 · JSH
Central Media
Microbiology · 85d
Cleared Nov 04, 1987
PROJECT 300 MICROASSAY BP-12, EIA MINILAB
K873451 · JJQ
Awareness Technology, Inc.
Chemistry · 69d
Cleared Nov 04, 1987
MEDIX BIOTECH FERRITIN ENZYME IMMUNOASSAY TEST KIT
K873730 · JMG
Medix Biotech, Inc.
Hematology · 50d
Cleared Nov 04, 1987
IMMUSTRIP(TM) SM ELISA TEST SYSTEM
K873741 · LKP
Immunomedics, Inc.
Immunology · 49d
Cleared Nov 04, 1987
GIANT RAGWEED ALLERGEN DISC
K873969 · DHB
Incstar Corp.
Immunology · 36d
Cleared Nov 04, 1987
TOTAL IGE FAST (TM) TEST PACKAGE
K873998 · DHB
3M Company
Immunology · 34d
Cleared Nov 04, 1987
SHOE COVERS
K874064 · FXP
Interpro Intl., Inc.
General Hospital · 30d
Cleared Nov 04, 1987
LAPAROTOMY SPONGES
K874065 · EFQ
Interpro Intl., Inc.
General & Plastic Surgery · 30d
Cleared Nov 04, 1987
SURGICAL CAPS
K874066 · FYF
Interpro Intl., Inc.
General & Plastic Surgery · 30d
Cleared Nov 04, 1987
1205 BETAPLATE LIQUID SCINTILLATION COUNTER
K874094 · JJJ
Lkb Instruments, Inc.
Chemistry · 35d
Cleared Nov 04, 1987
NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA)
K874115 · LKJ
Sigma Diagnostics, Inc.
Immunology · 26d
Cleared Nov 04, 1987
TITAN GEL REP CPK/LDH ISOENZYME CONTROL
K874141 · JJT
Helena Laboratories
Chemistry · 22d
Cleared Nov 04, 1987
FALSE RAGWEED ALLERGEN DISC
K874149 · DHB
Incstar Corp.
Hematology · 22d
Cleared Nov 04, 1987
JOHNSON GRASS ALLERGEN DISC
K874150 · DHB
Incstar Corp.
Immunology · 22d
Cleared Nov 04, 1987
EASY-TEST PHOSPHORUS (PHOS) ITEM NO. 16687
K874153 · CEO
Em Diagnostic Systems, Inc.
Chemistry · 22d
Cleared Nov 04, 1987
DART (R) ELECTROLYTE REAGENT SYSTEM
K874185 · JGS
Coulter Electronics, Inc.
Chemistry · 21d
Cleared Nov 04, 1987
SYNTRON BIORESEARCH U-TEST PREGNANCY TEST
K874248 · LCX
Syntron Bioresearch, Inc.
Chemistry · 19d