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
111697–111720 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 07, 1993
BECKMAN TRANSFERRIN KIT
K926272 · DDG
Beckman Instruments, Inc.
Immunology · 293d
Cleared Oct 07, 1993
SR SPECTRASIT, SR CHROMASIT
K930128 · EBF
Ivoclar North America, Inc.
Dental · 268d
Cleared Oct 07, 1993
MRINNERVU DISPOSABLE ENDORECTAL CERVIX COIL#BCR-15
K930779 · LNH
Medrad, Inc.
Radiology · 233d
Cleared Oct 07, 1993
FILLISCOPE
K930804 · CCW
Filliscope, Inc.
Anesthesiology · 233d
Cleared Oct 07, 1993
ARTOSCAN
K931022 · LNH
Biosound, Inc.
Radiology · 220d
Cleared Oct 07, 1993
EVIS 200 SYSTEM
K931154 · EOQ
Olympus Corp.
Ear, Nose, Throat · 213d
Cleared Oct 07, 1993
SURELOCK(TM) SNAPLESS MONITORING ELECTRODE
K931903 · DRX
Ludlow Technical Products
Cardiovascular · 175d
Cleared Oct 07, 1993
PM PUMP ASPIRATOR
K932494 · BTA
Precision Medical, Inc.
General & Plastic Surgery · 136d
Cleared Oct 07, 1993
EDGE SYSTEM
K932693 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 126d
Cleared Oct 07, 1993
SOFT-WEAR HEADGEAR AND SAFETY MODULES
K932761 · DZB
Professional Positioners, Inc.
Dental · 121d
Cleared Oct 07, 1993
SMARTNEEDLE(R) OVER-THE-NEEDLE CATHETER
K932777 · ITX
Peripheral Systems Group
Radiology · 121d
Cleared Oct 07, 1993
D1400 DEFIBRILLATOR W/ DEFIBRILLATION ADVISORY OPT
K932931 · MKJ
Zoll Medical Corp
Cardiovascular · 113d
Cleared Oct 07, 1993
HEARTTRACE LEFT VENTRICULAR ANALYSIS SOFTWARE
K933073 · IZI
Heartware Intl. Corp.
Radiology · 106d
Cleared Oct 07, 1993
LUMISCAN 50
K933129 · LMA
Lumisys, Inc.
Radiology · 101d
Cleared Oct 07, 1993
SPECTRUM DG-P7000 PEDIATRIC CRADLE
K933134 · KXH
Spectrum X-Ray Corp.
Radiology · 101d
Cleared Oct 07, 1993
ULTRA-VISION SUPER RAPID INTENSIFYING SCREEN
K933161 · EAM
Dupont Medical Products
Radiology · 100d
Cleared Oct 07, 1993
MRX-750
K933162 · ITY
Mrx Corp.
Radiology · 100d
Cleared Oct 07, 1993
STARKEY TYMPANETTE HEARING AID
K933407 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 87d
Cleared Oct 07, 1993
3-WAY HEAD IMMOBILIZER
K933613 · IYE
Bionix Development Corp.
Radiology · 80d
Cleared Oct 07, 1993
PITUITARY BOARD
K933614 · IYE
Bionix Development Corp.
Radiology · 80d
Cleared Oct 07, 1993
PHILIPS XRG 90 X-RAY GENERATOR SYSTEM
K933650 · IZO
Philips Medical Systems North...
Radiology · 72d
Cleared Oct 07, 1993
BOSCH EUROSTAR
K933988 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 51d
Cleared Oct 07, 1993
RESOLUTION ITC HEARING AID
K933989 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 51d
Cleared Oct 07, 1993
POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10
K934067 · DRK
National Custom Ent., Inc.
Cardiovascular · 48d