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
158545–158568 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 12, 1982
BACTEC NAP TB DIFFERENTIATION TEST
K822946 · JTO
Bd Becton Dickinson Vacutainer...
Microbiology · 39d
Cleared Nov 10, 1982
HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS
K822272 · HPQ
Kelleher Corp.
Ophthalmic · 104d
Cleared Nov 10, 1982
ALLERGENETICS IGE-FAST TEST
K822341 · DGC
Allergenetics
Immunology · 98d
Cleared Nov 10, 1982
ID-ZONE LD ISOENZYME CONTROL
K822984 · JJT
Beckman Instruments, Inc.
Chemistry · 29d
Cleared Nov 10, 1982
NML-TETRA-TUBE RIA
K823053 · CDX
Nuclear Medical Laboratories, Inc.
Chemistry · 23d
Cleared Nov 10, 1982
KENAMYCIN FLUORESCENT IMMUNOASSAY FIA
K823062 · KJI
American Diagnostic Corp.
Chemistry · 23d
Cleared Nov 10, 1982
CHALLENGER
K823084 · EJS
Bauer, Cheng & Associates, Inc.
Dental · 22d
Cleared Nov 10, 1982
NATURELLE
K823097 · EJS
Bauer, Cheng & Associates, Inc.
Dental · 22d
Cleared Nov 10, 1982
REX-CAPS
K823098 · EJJ
Bauer, Cheng & Associates, Inc.
Dental · 22d
Cleared Nov 10, 1982
RX MIDACAST
K823099 · EJT
Bauer, Cheng & Associates, Inc.
Dental · 22d
Cleared Nov 10, 1982
RX 91
K823100 · EJS
Bauer, Cheng & Associates, Inc.
Dental · 22d
Cleared Nov 10, 1982
GENERIC PREGNANCY TEST
K823109 · LCX
Diagnostic Specialties
Chemistry · 20d
Cleared Nov 10, 1982
CLAVICLE SUPPORT
K823157 · IQJ
Warm & Form, Orthopedic Materials
Physical Medicine · 16d
Cleared Nov 10, 1982
RIB BELT (UNIVERSAL)
K823158 · IPX
Warm & Form, Orthopedic Materials
Physical Medicine · 16d
Cleared Nov 10, 1982
DELUXE KNEE IMMOBILIZER
K823159 · ITQ
Warm & Form, Orthopedic Materials
Physical Medicine · 16d
Cleared Nov 10, 1982
ROTATION BOOT
K823160 · IQI
Warm & Form, Orthopedic Materials
Physical Medicine · 16d
Cleared Nov 10, 1982
CERVICAL COLLAR
K823161 · IQK
Warm & Form, Orthopedic Materials
Physical Medicine · 16d
Cleared Nov 10, 1982
UNIVERSAL SLING, SLING & SWATHE
K823162 · ILI
Warm & Form, Orthopedic Materials
Physical Medicine · 16d
Cleared Nov 10, 1982
UNIVERSAL BUCKS TRACTION
K823163 · KQZ
Warm & Form, Orthopedic Materials
Orthopedic · 16d
Cleared Nov 10, 1982
PELVIC TRACTION BELT
K823166 · ILZ
Warm & Form, Orthopedic Materials
Physical Medicine · 16d
Cleared Nov 08, 1982
DIA-SPEC
K822086 · HIB
Exitec, Inc.
Obstetrics & Gynecology · 118d
Cleared Nov 08, 1982
RED CELL LYSING REAGENT 78N 1915-1
K822324 · GGK
Interscience, Inc.
Hematology · 97d
Cleared Nov 08, 1982
FISCH DRILL PUMP
K822900
Teknar, Inc.
General & Plastic Surgery · 40d
Cleared Nov 08, 1982
SURGICAL PRODUCTS, SKIN STAPLE REMOVER
K822963 · FZQ
Temp-Stik Corp.
General & Plastic Surgery · 34d