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
146089–146112 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 13, 1985
MECRON UNCEMENTED STRUCTURED STEM HIP
K854191
Mecron Medical Products, Inc.
Orthopedic · 93d
Cleared Nov 13, 1985
ANADIAS NASAL SAW BLADES
K854192 · GFA
Anadias, Inc.
General & Plastic Surgery · 29d
Cleared Nov 13, 1985
NEEDLE W/STYLET FOR IMPLANTATION
K854238 · GAA
Microvasive
General & Plastic Surgery · 23d
Cleared Nov 13, 1985
SETMA FHT, MODEL ST 8130
K854263 · ILJ
Setma, Inc.
Physical Medicine · 21d
Cleared Nov 13, 1985
CAMBRIDGE MODEL XT1000
K854283 · IOL
Cambridge Medical Instruments, Inc.
Physical Medicine · 20d
Cleared Nov 13, 1985
SUBCUTANEOUS TUNNELING NEEDLES & HANDLES
K854327 · GCB
Concord Laboratories, Inc.
General & Plastic Surgery · 16d
Cleared Nov 13, 1985
AQUACEL SURGICAL PREP PADS
K854344 · FRO
Advanced Ortho-Technology, Inc.
General & Plastic Surgery · 15d
Cleared Nov 12, 1985
HOTIP HEMOSTATIC PROBE
K843628 · LNK
Trimedyne, Inc.
Gastroenterology & Urology · 424d
Cleared Nov 12, 1985
MODEL J25-25 WATT CO2 LASER
K851425 · HHR
Britt Corp., Inc.
Obstetrics & Gynecology · 216d
Cleared Nov 12, 1985
ANALYZER: NOVA STAT PROFILE 1 QUA CON MAT: ELECT
K852790 · CHL
Nova Biomedical Corp.
Hematology · 134d
Cleared Nov 12, 1985
CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR
K852929 · GQI
Microbix Biosystems, Inc.
Microbiology · 126d
Cleared Nov 12, 1985
VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO
K852930 · GQX
Microbix Biosystems, Inc.
Microbiology · 126d
Cleared Nov 12, 1985
HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT
K852931 · GQO
Microbix Biosystems, Inc.
Microbiology · 126d
Cleared Nov 12, 1985
MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLT
K852932 · GRF
Microbix Biosystems, Inc.
Immunology · 126d
Cleared Nov 12, 1985
NITROGLYCERIN INFUSION SET
K853019 · FPA
Lyphomed, Inc.
General Hospital · 118d
Cleared Nov 12, 1985
TECHNA VISION AUTO-PERIMETER
K853290 · HPT
Techna Vision
Ophthalmic · 99d
Cleared Nov 12, 1985
21 HEMATOLOGY REAGENTS
K853304 · GKZ
In Vitro Diagnostics, Inc.
Hematology · 99d
Cleared Nov 12, 1985
VIROGEN ROTATEST SLIDE TEST
K853399 · LIQ
Armkel, LLC
Microbiology · 92d
Cleared Nov 12, 1985
MCGAW/DROP WATCH FLOW MONITOR
K853549 · FLN
American Mcgaw
General Hospital · 78d
Cleared Nov 12, 1985
CADD-1, MODEL 5100 HF, AMBULATORY INFUSION PUMP
K853584 · FRN
Deltec Systems, Inc.
General Hospital · 78d
Cleared Nov 12, 1985
ACE-KYLE DYE INJECTION NEEDLE P/N 14082
K853604 · FMI
Today'S Machining & Design, Inc.
General Hospital · 76d
Cleared Nov 12, 1985
FRESENIUS DISPOSABLE BLOOD LINES
K853851 · FJK
Seratronics, Inc.
Gastroenterology & Urology · 57d
Cleared Nov 12, 1985
OPHTHALMIC LASER PHOTOCOAGULATOR
K853890 · HQF
Mira, Inc.
Ophthalmic · 54d
Cleared Nov 12, 1985
THROMBOPLASTIN-R REAGENT
K853986 · JPA
American Dade
Hematology · 46d