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
162049–162072 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 29, 1981
IMPROVED PLAYTEX TAMPON
K812870 · HEB
Playtex, Inc.
Obstetrics & Gynecology · 15d
Cleared Oct 28, 1981
ELUAID
K812002 · GGK
Ortho Diagnostic Systems, Inc.
Hematology · 106d
Cleared Oct 28, 1981
MOXALACTAM 30 MCG. SENSITIVITY DISCS
K812228 · JTN
Difco Laboratories, Inc.
Microbiology · 79d
Cleared Oct 27, 1981
INTERMEDICS ADAPTAID STEP-DOWN ADAPTER
K812812 · DTD
Intermedics, Inc.
Cardiovascular · 21d
Cleared Oct 27, 1981
INTERMEDICS PROGRAMMER, MODEL 522-03
K812813 · KRG
Intermedics, Inc.
Cardiovascular · 21d
Cleared Oct 27, 1981
IMED MODEL 970 & 975 VOL. INFUSION PUMP
K812823 · FRN
Imed Corp.
General Hospital · 19d
Cleared Oct 27, 1981
PRESSURE DISC COMPONENT FOR ACCUSET
K812824 · FRN
Imed Corp.
General Hospital · 19d
Cleared Oct 27, 1981
S/P SERUM DROPPER PIPETS
K812892 · KSS
American Dade
Hematology · 12d
Cleared Oct 26, 1981
FORCEP
K812205 · GEN
Reznik Instruments
General & Plastic Surgery · 83d
Cleared Oct 26, 1981
OXEQUIP CONDUCTIVE & NON ANES. BREATH
K812624 · CAI
Oxequip Health Ind.
Anesthesiology · 41d
Cleared Oct 26, 1981
ACMI BIPOLAR HEMOSTATIC SOURCE
K812637 · GEI
American Cystocope Makers, Inc.
General & Plastic Surgery · 41d
Cleared Oct 26, 1981
REPLACEABLE BATTERY PERFECTEMP 2 CAUT
K812644 · GEI
Key Medical, Inc.
General & Plastic Surgery · 39d
Cleared Oct 26, 1981
WHISK-R
K812694 · GEE
Medi-Spec
General & Plastic Surgery · 34d
Cleared Oct 26, 1981
THORACIC DRAINAGE SET #55-DB2-G
K812746 · KDQ
J. H. Emerson Co.
General Hospital · 27d
Cleared Oct 26, 1981
EXTENSIONS-LUSATZTISCH
K812779 · HST
The Telos Co.
Neurology · 21d
Cleared Oct 26, 1981
H-103 IGG, H-104 IGA, H-105 IGM
K812821 · DFZ
Immulok, Inc.
Immunology · 19d
Cleared Oct 26, 1981
FLO-COR I
K812825 · JAX
Biotrine Corp.
Anesthesiology · 18d
Cleared Oct 26, 1981
IDS PORPHYRIN REAGENT
K812859 · JTO
Innovative Diagnostic Systems, Inc.
Microbiology · 13d
Cleared Oct 26, 1981
IMMUNOASSAY PLATE
K812860 · JTC
Skatron, Inc.
Microbiology · 13d
Cleared Oct 26, 1981
API GERM TUBE
K812862 · JTO
Analytab Products, Inc.
Microbiology · 13d
Cleared Oct 26, 1981
OPTIONAL TOTAL CA-MODULE FOR IL 504/508
K812872 · CIS
Instrumentation Laboratory CO
Chemistry · 12d
Cleared Oct 26, 1981
PENASE
K812877 · JTO
Analytab Products, Inc.
Chemistry · 12d
Cleared Oct 26, 1981
IMMUNEX CRP
K812881 · DCN
Armkel, LLC
Immunology · 12d
Cleared Oct 26, 1981
RHEUMATEX
K812882 · DHR
Armkel, LLC
Microbiology · 12d