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
125545–125568 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 22, 1990
DOBBHOFF BILIARY STENT SET
K901582 · FGE
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 79d
Cleared Jun 22, 1990
SHIN NIPPON AUTO REFRACTOMETER QR-007N
K901583 · HKO
Soderberg, Inc.
Ophthalmic · 79d
Cleared Jun 22, 1990
OHMEDA - OHIO(R) CARE PLUS INCUBATOR
K901585 · FMZ
Ohmeda Medical
General Hospital · 79d
Cleared Jun 22, 1990
DIAMOND ND:YAG OPHTHALMIC LASER
K901636 · GEX
Biovision, Inc.
General & Plastic Surgery · 74d
Cleared Jun 22, 1990
CAREFREE(TM) FESTIVA PANTYSHIELDS
K901664 · HHD
Personal Products Co.
Obstetrics & Gynecology · 73d
Cleared Jun 22, 1990
PALADON(R) 65
K901789 · EBI
Kulzer, Inc.
Dental · 64d
Cleared Jun 22, 1990
ALLEVYN DRESSING (LABELING REVISED)
K901877 · KMF
Smith & Nephew United, Inc.
General & Plastic Surgery · 57d
Cleared Jun 22, 1990
INTRASITE GEL (LABELING REVISION)
K901878 · KMF
Smith & Nephew United, Inc.
General & Plastic Surgery · 57d
Cleared Jun 22, 1990
INTRASITE HYDROCOLLOID DRESSING (REVISED LABELING)
K901879 · KGX
Smith & Nephew United, Inc.
General & Plastic Surgery · 57d
Cleared Jun 22, 1990
SILAMAT (AMALGAMATOR)
K901909 · EFD
Ivoclar North America, Inc.
Dental · 56d
Cleared Jun 22, 1990
SPECIAL BOND
K901916 · EBF
Ivoclar North America, Inc.
Dental · 57d
Cleared Jun 22, 1990
CONTACT MOLAR BANDS AND CONTOUR STRIPS
K901919 · DZN
Ivoclar North America, Inc.
Dental · 57d
Cleared Jun 22, 1990
VKS-1 VIDEO KERATOSCOPE
K902012 · HLQ
Computed Anatomy, Inc.
Ophthalmic · 50d
Cleared Jun 22, 1990
LATEX EXAMINATION GLOVES
K902459 · LYY
Yue XI State Farms Latex Products...
General Hospital · 18d
Cleared Jun 22, 1990
WEEVAC 6 INFANT EVACUATION STRETCHER
K902521 · FPP
W. Murphy Ent., Inc.
General Hospital · 15d
Cleared Jun 22, 1990
GRI LASERGRAPH(TM) ECG PAPER
K902586 · DSF
Gri Medical Products, Inc.
Cardiovascular · 10d
Cleared Jun 21, 1990
PLASMA TFE VASCULAR PROSTHESIS MODIFIED INSTRUC.
K896964 · DSY
Medtronic Vascular
Cardiovascular · 188d
Cleared Jun 21, 1990
SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO
K897141 · JDN
Stuart
Orthopedic · 176d
Cleared Jun 21, 1990
DATASCOPE SLIDEWIRE(TM)
K901347 · DQX
Datascope Corp.
Cardiovascular · 90d
Cleared Jun 21, 1990
ESOPHAGEAL BALLOON DILATOR
K901424 · KNQ
Telemed Systems, Inc.
Gastroenterology & Urology · 87d
Cleared Jun 21, 1990
PYLORIC BALLOON DILATOR
K901425 · FAT
Telemed Systems, Inc.
Gastroenterology & Urology · 87d
Cleared Jun 21, 1990
COLONIC BALLOON DILATOR
K901426 · FFP
Telemed Systems, Inc.
Gastroenterology & Urology · 87d
Cleared Jun 21, 1990
BILIARY BALLOON DILATOR
K901432 · FGE
Telemed Systems, Inc.
Gastroenterology & Urology · 87d
Cleared Jun 21, 1990
SURE-FLEX ANASTOMOTIC BALLOON DILATOR
K901433 · FGE
Telemed Systems, Inc.
Gastroenterology & Urology · 87d