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
155377–155400 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 14, 1983
PARAMAX & GLUTAMYTRANSFERASE REAGENT
K833001 · JQB
American Dade
Chemistry · 63d
Cleared Oct 14, 1983
PARAMAX PHOSPHORUS REAGENT
K833002 · CEO
American Dade
Chemistry · 63d
Cleared Oct 14, 1983
PARAMAX TOTAL BILIRUBIN REAGENT
K833004 · CIG
American Dade
Chemistry · 63d
Cleared Oct 14, 1983
BIOPLAR CORD -DISPOSABLE 30-1538
K833015 · GEI
Codman & Shurtleff, Inc.
General & Plastic Surgery · 38d
Cleared Oct 14, 1983
TISSUE TRANSPORT MEDIUM
K833016 · KIT
Northern Scientific, Inc.
Microbiology · 38d
Cleared Oct 14, 1983
CAMPYLOBACTER-SELECTIVE SUPPLE-SKIRROW
K833018 · JSK
Gibco Laboratories Life Technologies,...
Microbiology · 38d
Cleared Oct 14, 1983
CAMPYLOBACTER SELECTIVE SUPPLE-BLASER
K833019 · JSK
Gibco Laboratories Life Technologies,...
Microbiology · 38d
Cleared Oct 14, 1983
CAMPYLOBACTER SELECTIVE SUPPLE-BUTZLER
K833020 · JSK
Gibco Laboratories Life Technologies,...
Microbiology · 38d
Cleared Oct 14, 1983
AIR UTERINE DISPLACER-AUD 120
K833022 · CCX
Scientific Sales Intl., Inc.
Anesthesiology · 38d
Cleared Oct 14, 1983
TECHNICON PARACUT
K833071 · KEO
Technicon Instruments Corp.
Pathology · 36d
Cleared Oct 14, 1983
MASTERHINGE
K833084 · LGF
Mark One Healthcare Products
Orthopedic · 31d
Cleared Oct 14, 1983
SENSORY ROLLER MASSAGER
K833090 · ISA
Maddak, Inc.
Physical Medicine · 32d
Cleared Oct 12, 1983
QUANTUM BIPOLAR CARDIAC PULSE GENERATOR
K831633 · DXY
Intermedics, Inc.
Cardiovascular · 145d
Cleared Oct 06, 1983
STRAIGHT STEM FEMORAL HEAD PROSTHESIS
K831851 · KWL
Proteck, Inc.
Orthopedic · 119d
Cleared Oct 06, 1983
EGS MODEL 300
K832371
Electro-Med Health Industries, Inc.
Dental · 80d
Cleared Oct 05, 1983
CHLAMYDIAZYME, ENZYME IMMUNOASSAY DETEC
K831962 · LJC
Abbott Laboratories
Chemistry · 110d
Cleared Oct 04, 1983
C-LOOPS
K830800 · KDC
Concept, Inc.
General & Plastic Surgery · 204d
Cleared Oct 04, 1983
MED CARE PREP RAZOR
K831374
Medcare Products
General & Plastic Surgery · 160d
Cleared Oct 04, 1983
DIXIE USA PTL, PHARYNGEAL TRACHEAL LUMEN
K831481 · DSK
Eugene Scarberry
Cardiovascular · 148d
Cleared Oct 04, 1983
ATRIUM THORACIC CATHETER
K831931 · GBZ
Atrium Medical Corp.
General & Plastic Surgery · 111d
Cleared Oct 04, 1983
ACETAMINOPHER ASSAY KIT
K832045 · LDP
Quantimetrix Corp.
Toxicology · 102d
Cleared Oct 04, 1983
PSI SURGICAL ASPIRATOR
K832100 · BTA
Advanced Biosearch Assn.
General & Plastic Surgery · 97d
Cleared Oct 04, 1983
SELF CHECK DIGITAL BLOOD PRESS. MONITOR
K832171 · DXN
Ritter Co.
Cardiovascular · 90d
Cleared Oct 04, 1983
HOT PROBE MODEL 6001
K832179 · EEG
Analytic Technology
Dental · 90d