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
145825–145848 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 06, 1985
ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2
K842663 · GQO
Amico Lab, Inc.
Immunology · 514d
Cleared Dec 06, 1985
ARTHOPOR-ACETABULAR COMPONENT
K844050 · JDI
Joint Medical Products Corp.
Orthopedic · 415d
Cleared Dec 06, 1985
CLEANING KIT CARE & CLEANING OF TRACHEAL T-TUBE
K853419 · BTO
Hood Laboratories
Anesthesiology · 114d
Cleared Dec 06, 1985
ORTHO CHLAMYDIA DIRECT DETECTION (FA) TEST
K853738 · LJP
Ortho Diagnostic Systems, Inc.
Microbiology · 91d
Cleared Dec 06, 1985
DEDO SUCTION CANNULA
K854005 · GEA
Dedo Manufacturer, Inc.
General & Plastic Surgery · 67d
Cleared Dec 06, 1985
EMPI, NMS/SUE CUTANEOUS ELECTRODE
K854513 · GXY
Empi
Neurology · 24d
Cleared Dec 06, 1985
PENICILLIN/STREPTOMYCIN SOLUTION
K854567 · KIT
Mediatech, Inc.
Pathology · 22d
Cleared Dec 06, 1985
MINI MASH 2000
K854602 · LIB
Dynatech Corp.
Pathology · 18d
Cleared Dec 06, 1985
MULTI MASH 2000
K854603 · LIB
Dynatech Corp.
Pathology · 18d
Cleared Dec 06, 1985
AUTO MASH
K854604 · LIB
Dynatech Corp.
Microbiology · 18d
Cleared Dec 05, 1985
ABBOTT STREP A P.S.D.
K852266 · GTZ
Abbott Laboratories
Microbiology · 191d
Cleared Dec 05, 1985
LBK 1244 DELFIA HCG KIT
K852760 · JHI
Lkb Instruments, Inc.
Chemistry · 160d
Cleared Dec 05, 1985
ADDITIVE EXTENSION SYRINGE
K853120 · FMF
Abbott Laboratories
General Hospital · 133d
Cleared Dec 05, 1985
REPLACEMENT PUMP TUBING
K853621 · JJE
Shaban Mfg. Co.
Chemistry · 98d
Cleared Dec 05, 1985
RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR
K853848 · BXW
Medical Graphics Corp.
Anesthesiology · 80d
Cleared Dec 05, 1985
COMPUTERIZED RADIATION TREATMENT PLANNING SYS
K853964 · LHN
Computerized Medical Systems, Inc.
Radiology · 80d
Cleared Dec 05, 1985
PARAGON ELECTROPHORESIS SYS LIPOPROTEIN REAGENT TE
K854057 · JHO
Beckman Instruments, Inc.
Chemistry · 63d
Cleared Dec 05, 1985
IMMUCHEM V.I.P.(VISUAL INDICATED PREGNANCY)
K854104 · JHI
Immunchem Corp.
Chemistry · 58d
Cleared Dec 05, 1985
I.V. WATCH
K854172 · FPB
Alltek, Inc.
General Hospital · 51d
Cleared Dec 05, 1985
TERUMO SENSIBEAD EIA COLORIMETER
K854210 · JJQ
Terumo Medical Corp.
Chemistry · 50d
Cleared Dec 05, 1985
PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT
K854324 · CDX
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 38d
Cleared Dec 05, 1985
TOBRAMYCIN KIT(FPIA)FLUORESCENCE POLARIZATION IMMU
K854392 · LFW
Windsor Laboratories, Inc.
Toxicology · 35d
Cleared Dec 05, 1985
CHURCHILL-H NON-VENTED IV SET
K854435 · FPA
Churchill Corp.
General Hospital · 30d
Cleared Dec 05, 1985
CHURCHILL-H SCALP VEIN SET
K854436 · FPA
Churchill Corp.
General Hospital · 30d