FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
128929–128952 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 08, 1989
HUMAN (IGG) SUBCLASS (EIA) KIT
K895600 · DAS
The Binding Site, Ltd.
Immunology · 51d
Cleared Nov 08, 1989
DAILY ACTIVITY ASSIST DEVICE (MOBILE STANDING AID)
K895686 · IPL
Stand-N-Go Corp.
Physical Medicine · 47d
Cleared Nov 08, 1989
THE DOCTOR'S CHOICE ELECTRODE
K895737 · GEI
The Skin Care Centre
General & Plastic Surgery · 43d
Cleared Nov 08, 1989
HOLLOW FIBER DIALYZER SERIES FOCUS 160/160H
K895759 · KDI
National Medical Care, Medical...
Gastroenterology & Urology · 43d
Cleared Nov 08, 1989
ASNIS II GUIDED BONE SCREW
K895766 · HWC
Howmedica Corp.
Orthopedic · 43d
Cleared Nov 08, 1989
SHANNON LATEX MEDICAL GLOVES
K895804 · LYY
Cashmor Mfg. , Ltd.
General Hospital · 41d
Cleared Nov 08, 1989
ONE TOUCH II METER
K895911 · CGA
Lifescan, Inc.
Chemistry · 29d
Cleared Nov 08, 1989
WAKO(TM) AUTOKIT GAMMA-GT
K895984 · JPZ
Wako Chemicals USA, Inc.
Chemistry · 26d
Cleared Nov 08, 1989
CEDIA DIGITOXIN ASSAY
K896021 · LFM
Microgenics Corp.
Toxicology · 23d
Cleared Nov 08, 1989
SURGI-BRUSH
K896085 · GEC
Sparta Surgical Corp.
General & Plastic Surgery · 20d
Cleared Nov 08, 1989
REFLUX BED
K896256 · INW
Cozcon, Inc.
Physical Medicine · 8d
Cleared Nov 08, 1989
QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL)
K896271 · DHR
Biokit USA, Inc.
Immunology · 9d
Cleared Nov 08, 1989
QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL
K896272 · DCN
Biokit USA, Inc.
Immunology · 9d
Cleared Nov 08, 1989
SURGEON'S GLOVES
K896327 · KGO
Productes Del Latex, S.A.
General Hospital · 6d
Cleared Nov 07, 1989
PATIENT EXAMINATION GLOVES
K891182 · LYY
Raystar Engineering & Construction...
General Hospital · 246d
Cleared Nov 07, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892076 · LYY
M/S Shanghai Knitwear Import & Export...
General Hospital · 218d
Cleared Nov 07, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892571 · LYY
Sinopac Marketing, Inc.
General Hospital · 211d
Cleared Nov 07, 1989
PATIENT EXAMINATION GLOVES
K893075 · LYY
Quality Latex Corp. Sdn Bhd
General Hospital · 208d
Cleared Nov 07, 1989
LATEX EXAMINATION GLOVES
K893804 · LYY
S-P Pantec Co., Ltd.
General Hospital · 169d
Cleared Nov 07, 1989
LATEX EXAM GLOVES (MFG: CHINA NAT CHEM CONST CORP)
K894194 · LYY
Invent Ent. (U.S.A.) Corp.
General Hospital · 146d
Cleared Nov 07, 1989
WESTCO MADAYAG PAB NEEDLE
K894387 · HAW
Western Medical, Ltd.
Neurology · 113d
Cleared Nov 07, 1989
LATEX PATIENT EXAMINATION GLOVES
K894967 · LYY
Yan Ling Rubber Products Co.
General Hospital · 92d
Cleared Nov 07, 1989
HEIMLICH MICRO TRACH
K895130 · BTO
Ballard Medical Products
Anesthesiology · 82d
Cleared Nov 07, 1989
BLOOD GAS SAFETY SYRINGE
K895171 · CBT
Kronner Medical
Anesthesiology · 89d