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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
100009–100032 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 17, 1995
CEDIA DAU METHADONE ASSAY
K954227 · DJR
Microgenics Corp.
Toxicology · 67d
Cleared Nov 17, 1995
CLEAN ROOM WHEELCHAIR
K954328 · IOR
Forth Research, Inc.
Physical Medicine · 63d
Cleared Nov 17, 1995
MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL...
K954391 · DRL
Bio-Tek Instruments, Inc.
Cardiovascular · 59d
Cleared Nov 17, 1995
K-DEFIB/PACE PEDIATRIC ELECTRODE
K954504 · MKJ
Katecho, Inc.
Cardiovascular · 50d
Cleared Nov 16, 1995
ECHOMARK INTRAUTERINE GUIDING CATHETER
K932436 · MOV
Echocath, Inc.
Obstetrics & Gynecology · 911d
Cleared Nov 16, 1995
PROTECTRODE SYSTEMS CONCENTRIC
K932691 · IKT
The Electrode Store, Inc.
Neurology · 897d
Cleared Nov 16, 1995
KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE
K935716 · HIH
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 716d
Cleared Nov 16, 1995
HYSTERSCOPE
K940316 · HIH
Stephen Chakoff, Inc.
Obstetrics & Gynecology · 661d
Cleared Nov 16, 1995
GLOBAL MEDICAL PRODUCTS CHIBA, FRANSEEN, WESTCOTT STYLE, MENGHINI, TURNER,...
K951421 · FCG
Global Medical Products, Ltd.
Gastroenterology & Urology · 233d
Cleared Nov 16, 1995
BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP
K951770 · IKK
Biodex Medical Systems, Inc.
Physical Medicine · 213d
Cleared Nov 16, 1995
CMV IGG HUMAN SERUM CONTROLS
K951800 · GQI
Pyramid Biological Corp.
Microbiology · 212d
Cleared Nov 16, 1995
ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS
K952254 · GQI
Pyramid Biological Corp.
Microbiology · 185d
Cleared Nov 16, 1995
SHARPLAN MODEL 2040 PULSED CTH:YAG SURGICAL LASER SYSTEM
K952277 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 185d
Cleared Nov 16, 1995
MID-STREAM COLLECTION SET-STERILE
K953929 · LIO
Trinity Laboratories, Inc.
Microbiology · 87d
Cleared Nov 16, 1995
KREUZER CEILING MOUNTED SUPPORT SYSTEMS, KLINOPORT
K953980 · FQO
Kreuzer Corp.
General & Plastic Surgery · 85d
Cleared Nov 16, 1995
RIZA-RIBE NEEDLE (MODIFICATION)
K954882 · HRX
R-Med, Inc.
Orthopedic · 98d
Cleared Nov 15, 1995
SIMS SILO NEEDLE DE-ACCESS ENCLOSURE
K935767 · LJT
Sims Deltec, Inc.
General Hospital · 713d
Cleared Nov 15, 1995
NON-CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES
K942855 · LYY
Evergrade Healthcare Products Sdn Bhd
General Hospital · 517d
Cleared Nov 15, 1995
NEUROLOGICAL DIAGNOSTIC DEVICES
K943449 · GXY
Henley Intl.
Neurology · 485d
Cleared Nov 15, 1995
SMARTDOSE IV PREFILLED INFUSION CONTAINER
K944351 · FRN
River Medical, Inc.
General Hospital · 435d
Cleared Nov 15, 1995
SMARTDOSE III INFUSION CONTAINER
K944352 · FRN
River Medical, Inc.
General Hospital · 435d
Cleared Nov 15, 1995
INTEGRAL VII 4.9MM BIOINTEGRATED DENTAL IMPLANT SYSTEM
K946319 · DZE
Calcitek, Inc.
Dental · 322d
Cleared Nov 15, 1995
INTEGRAL VIII BIOINTEGRATED DENTAL IMPLANT SYSTEM
K946345 · DZE
Calcitek, Inc.
Dental · 320d
Cleared Nov 15, 1995
SUCTION TIP CLEANER CUP
K952219 · GCX
Moore/Gobel
General Hospital · 188d