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
127345–127368 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 02, 1990
DOBBHOFF(R) ERCP CANNULA
K896518 · FGE
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 79d
Cleared Feb 02, 1990
DMV(R) VENEER SUCTION GRIPPER
K896565 · EKJ
Dmv Corp.
Dental · 77d
Cleared Feb 02, 1990
VIRAL RESPIRATORY INDIRECT FLUORES. MONO. ANTIBODY
K896635 · GNW
Baxter Healthcare Corp
Microbiology · 72d
Cleared Feb 02, 1990
MF-450 ELECTROSURGICAL UNIT 60-5500-001
K896839 · GEI
Aspen Laboratories, Inc.
General & Plastic Surgery · 59d
Cleared Feb 02, 1990
BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500
K900210 · HSZ
Micro-Aire Surgical Instruments, Inc.
Orthopedic · 16d
Cleared Feb 02, 1990
ROMCHECK SPECIMEN COLLECTION KIT
K900225 · LIO
Adeza Biomedical
Microbiology · 16d
Cleared Feb 02, 1990
ET-RESTRAINT CAT. # ER 4000
K900236 · CBH
Ventlab Corp.
Anesthesiology · 16d
Cleared Feb 02, 1990
ANTI-SSA MICROASSAY AND ANTI-SSB MICROASSAY
K900241 · LLL
Diamedix Corp.
Immunology · 16d
Cleared Feb 01, 1990
INTER-PAL C-19 AND INTER-PAL C-38
K890294 · JAQ
Enrad Corp.
Radiology · 378d
Cleared Feb 01, 1990
HEMOLASER HEMOSCOPE
K893816 · LYK
Hemolaser Corp.
Cardiovascular · 254d
Cleared Feb 01, 1990
THERATRON 1000
K894165 · IWB
Theratronics, Inc.
Radiology · 230d
Cleared Feb 01, 1990
AVL MODEL 995HB PH/BLOOD GAS ANALYZER
K895317 · CHL
Avl Scientific Corp.
Chemistry · 156d
Cleared Feb 01, 1990
RECTILINEAR SCANNER MODEL #187-270
K895799 · IYW
Atomic Products Corp.
Radiology · 126d
Cleared Feb 01, 1990
PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1
K895839 · LJP
Diagnostic Products Corp.
Microbiology · 121d
Cleared Feb 01, 1990
MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133M
K896125 · IYT
Medipart Jerry Alexander
Radiology · 101d
Cleared Feb 01, 1990
SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER
K896203 · CAK
Solco Basle, Inc.
General Hospital · 98d
Cleared Feb 01, 1990
ARGELITE 80 + 5 DENTAL ALLOY FOR PORCELAIN APPL.
K896348 · EJT
Argen Precious Metals, Inc.
Dental · 90d
Cleared Feb 01, 1990
VARI/MOIST WOUND DRESSING
K896358 · KGX
Catalina Biomedical Corp.
General & Plastic Surgery · 87d
Cleared Feb 01, 1990
MODIFIED GLUMA BONDING SYSTEM
K896382 · KLE
Heraeus Kulzer, Inc.
Dental · 87d
Cleared Feb 01, 1990
GAS MIXTURES AS DEVICE COMPONENTS
K896412 · GEX
Spectra Gases, Inc.
General & Plastic Surgery · 85d
Cleared Feb 01, 1990
COMBINATION 6X-MAGNIFIER AND TWEEZERS
K896413 · LRR
James Alexander Corp.
General & Plastic Surgery · 85d
Cleared Feb 01, 1990
RUBBER LATEX SURGEON'S GLOVE
K896432 · KGO
Regent Hospital Products
General Hospital · 85d
Cleared Feb 01, 1990
DEVILBISS MODEL PV02 SERIES
K896457 · CAW
Devilbiss Health Care, Inc.
Anesthesiology · 80d
Cleared Feb 01, 1990
EXTENSION SET
K896561 · FPA
Westmark, Sterile Packing Systems,...
General Hospital · 76d