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
98353–98376 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 28, 1996
CONNECTING TUBING
K960218 · BYY
Custom Pack Reliability
General Hospital · 72d
Cleared Mar 28, 1996
CPR YANKAUER
K960223 · GCX
Custom Pack Reliability
General Hospital · 72d
Cleared Mar 28, 1996
CPR LAP SPONGES
K960236 · GDY
Custom Pack Reliability
General & Plastic Surgery · 72d
Cleared Mar 28, 1996
CPR SUTURE REMOVAL KIT
K960238 · FRG
Custom Pack Reliability
General Hospital · 72d
Cleared Mar 28, 1996
STAR TITAN SERIES MOTORS & ATTACHMENTS
K960260 · EFA
Dentalez Group
Dental · 70d
Cleared Mar 28, 1996
HA & TPS RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM
K960288 · DZE
Lifecore Biomedical, Inc.
Dental · 66d
Cleared Mar 28, 1996
ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000)
K960365 · KLE
Wallace A. Erickson & Co.
Dental · 63d
Cleared Mar 28, 1996
FREESOFT (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS
K960376 · LPL
Unilens Corp., USA
Ophthalmic · 62d
Cleared Mar 28, 1996
SEESOFT (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS
K960380 · LPL
Unilens Corp., USA
Ophthalmic · 62d
Cleared Mar 28, 1996
STAR DENTAL PUSHBUTTON AUTOCHUCK REPLACEMENT TURBINE FOR MIDWEST HANDPIECES
K960507 · EFA
Dentalez Group
Dental · 52d
Cleared Mar 28, 1996
BEMIS ONE QUART PHLEBOTOMY CONTAINER (PART NUMBER 100)
K960525 · MMK
Bemis Mfg. Co.
General Hospital · 52d
Cleared Mar 28, 1996
LYNX DPA DISPOSABLE PROPHY ANGLE
K960541 · EFB
Mti Precision Products
Dental · 50d
Cleared Mar 28, 1996
MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED)
K960653 · GAN
Ethicon, Inc.
General & Plastic Surgery · 42d
Cleared Mar 28, 1996
STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE
K960719 · EFA
Dentalez Group
Dental · 36d
Cleared Mar 28, 1996
INDERMIL DENTAL
K960910 · EMA
Loctite Corp.
Dental · 23d
Cleared Mar 27, 1996
SUPERSTAND 300
K935123 · IYB
Wuestec Medical, Inc.
Radiology · 881d
Cleared Mar 27, 1996
GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE,...
K951448 · DRC
Global Medical Products, Ltd.
Cardiovascular · 364d
Cleared Mar 27, 1996
DIASONICS MASTERS SERIES 5000 ULTRASOUND SCANNER
K951998 · IYN
Diasonics Ultrasound
Radiology · 334d
Cleared Mar 27, 1996
CPR PROMPT
K954692 · LIX
County Line , Ltd.
Cardiovascular · 168d
Cleared Mar 27, 1996
NEVOSCOPE
K954943 · KZF
Nizar A. Mullani
General Hospital · 149d
Cleared Mar 27, 1996
WESTMED CIRCULARIE PEP DEVICES
K955047 · BYE
Westmed Intl.
Anesthesiology · 145d
Cleared Mar 27, 1996
COMPACT COTREL-DUBOUSSET (CCD) SPINAL SYSTEM
K955365 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 126d
Cleared Mar 27, 1996
SENTRY DISPOSABLE DISPERSIVE ELECTRODE
K955636 · JOS
Sentry Medical Products, Inc.
General & Plastic Surgery · 107d
Cleared Mar 27, 1996
MODULAR ACETABULAR SHELL II
K955739 · LPH
Intermedics Orthopedics
Orthopedic · 100d