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
107881–107904 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 10, 1994
CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM
K935092 · FMF
Contour Fabricators of Florida, Inc.
General Hospital · 228d
Cleared Jun 10, 1994
SCHNEIDER GUIDEZILLA SOFTIP GUIDING CATHETER
K935292 · DQY
Boston Scientific Scimed, Inc.
Cardiovascular · 220d
Cleared Jun 10, 1994
ALPHA-DENT GLASS IONOMER CEMENT, SELF CURED
K935436 · EMA
Wallace A. Erickson & Co.
Dental · 212d
Cleared Jun 10, 1994
SYRIGENE ACETIC ACID PRE-FILLEDSYRINGE
K935643 · KNY
Regulatory & Marketing Services, Inc.
Gastroenterology & Urology · 196d
Cleared Jun 10, 1994
IV START KIT
K935684 · LRS
Cush Medical Products
General & Plastic Surgery · 193d
Cleared Jun 10, 1994
MID-500
K940117 · MEB
Block Medical, Inc.
General Hospital · 151d
Cleared Jun 10, 1994
DIAL MEDICAL SUPPLY FISTULA NEEDLE SET
K940441 · FOZ
Dial Medical of Florida, Inc.
General Hospital · 130d
Cleared Jun 10, 1994
SELISA ANTI-N DNA ANTIBODIES
K940585 · LRM
Cambridge Life Sciences Plc.
Immunology · 122d
Cleared Jun 10, 1994
AUTOZYME SCREEN
K940700 · LJM
Cambridge Life Sciences Plc.
Immunology · 114d
Cleared Jun 10, 1994
SMARTNEEDLE VASCULAR ACCESS SYSTEM, MODIFICATION
K940804 · ITX
Peripheral Systems Group
Radiology · 123d
Cleared Jun 10, 1994
ACCESSORIES, SURGICAL CAMERA
K940988 · GCJ
Woodbine Optical Corp.
General & Plastic Surgery · 98d
Cleared Jun 10, 1994
ENA SCREEN ELISA TEST SYSTEM
K941014 · LJM
Zeus Scientific, Inc.
Immunology · 99d
Cleared Jun 10, 1994
MODEL TI500 ISOLETTE INFANT INCUBATOR
K941106 · FPL
Air-Shields, Inc.
General Hospital · 95d
Cleared Jun 10, 1994
MDT SHAMPAINE 5100B AND 5100E SURGICAL TABLES
K941150 · FQO
Mdt Technology For Life
General & Plastic Surgery · 92d
Cleared Jun 10, 1994
STERILE WOUND HYDROGEL DRESSING
K941339 · MGQ
Renaissance Pharmaceutical, Inc.
General & Plastic Surgery · 81d
Cleared Jun 10, 1994
ENA PROFILE-6 ELISA TEST SYSTEM
K941409 · LJM
Zeus Scientific, Inc.
Immunology · 79d
Cleared Jun 10, 1994
ULTRACAM II
K941452 · EIA
Dental Vision Direct, Inc.
Dental · 78d
Cleared Jun 10, 1994
FLUORIDE-PSA PRIME/ADHESIVE
K941572 · KLE
Dentsply Intl.
Dental · 71d
Cleared Jun 10, 1994
CAULK TOOTH CONDITIONER GEL AND SYRINGE
K942031 · EBF
Dentsply Intl.
Dental · 45d
Cleared Jun 10, 1994
BARD ENDOSCOPIC OVERTUBE
K942044 · FED
C.R. Bard, Inc.
Gastroenterology & Urology · 43d
Cleared Jun 10, 1994
AESCULAP INTERCHANGEABLE TROCAR INSTRUMENT SET
K942053 · GCJ
Aesculap, Inc.
General & Plastic Surgery · 43d
Cleared Jun 10, 1994
TUBLI-SEAL EWT
K942393 · KIF
Sybron Dental Specialties, Inc.
Dental · 22d
Cleared Jun 10, 1994
KYOKKO UM SERIES INTENSIFYING SCREEN
K942399 · EAM
Fujifilm Medical System U.S.A., Inc.
Radiology · 22d
Cleared Jun 10, 1994
MASS SPECTROMETRY MONITORING LINES AND CONNECTORS
K942567 · CCK
Med-Plastics Intl., Inc.
Anesthesiology · 10d