Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
159385–159408 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 1982
SIDEWINDER OMNI WHEELCHAIR DIRECT/POWER
K823175 · ITI
Kinetic Concepts, Inc.
Physical Medicine · 21d
Cleared Nov 16, 1982
CHLAMYDIA TRANSETTEE 1 & 3
K823179 · JSM
Spectrum Co.
Microbiology · 21d
Cleared Nov 16, 1982
RAPID PRESUMPTIVE IDENT. GPA STREP
K823198 · JTO
Microchemical Specialities, Co.
Microbiology · 21d
Cleared Nov 16, 1982
DISPOSABLE DISPENSE MANIFOLD
K823218 · JTC
Dynatech Laboratories, Inc.
Microbiology · 19d
Cleared Nov 16, 1982
THERMAX
K823245 · KYA
American Thermometer Company, Inc.
Radiology · 15d
Cleared Nov 16, 1982
U-WAY QUICKOLLAR
K823247 · IQK
Ems Industries, Inc.
Physical Medicine · 15d
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