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
107161–107184 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 29, 1994
BELTONE SERIES 100 AUDIOMETERS
K940216 · EWO
Beltone Electronics Corp.
Ear, Nose, Throat · 196d
Cleared Jul 29, 1994
COVERLET ADHESIVE DRESSING
K940378 · KGX
Beiersdorf, Inc.
General & Plastic Surgery · 184d
Cleared Jul 29, 1994
NOVA MICROSONICS ACCESS IMAGE MANAGEMENT NETWORK/ACCESS ACQUISITION MODULE
K940423 · LMD
Advanced Technology Laboratories, Inc.
Radiology · 179d
Cleared Jul 29, 1994
UMBILI-CATH-S-DL
K940952 · FOS
Gesco Intl., Inc.
General Hospital · 150d
Cleared Jul 29, 1994
CTS SYSTEM
K941004 · IYB
Acoma Medical Imaging, Inc.
Radiology · 150d
Cleared Jul 29, 1994
F/C/W TUBESTAND
K941017 · IYB
Acoma Medical Imaging, Inc.
Radiology · 148d
Cleared Jul 29, 1994
TSX-002A (XVISION) CT SCANNER
K941745 · JAK
Toshiba America Medical Systems, In.C
Radiology · 113d
Cleared Jul 29, 1994
ISG MEDICAL IMAGING FAMILY OF WORKSTATIONS (MIFW)
K941933 · LLZ
I.S.G. Technologies, Inc.
Radiology · 100d
Cleared Jul 29, 1994
UNSCENTED MENSTRUAL TAMPON
K941936 · HEB
Johnson & Johnson Worldwide
Obstetrics & Gynecology · 100d
Cleared Jul 29, 1994
DPD-3
K942092 · IYE
Scanditronix, Inc.
Radiology · 88d
Cleared Jul 29, 1994
SNAC (SIEMENS NUCLEAR ACQUISITION COMPUTER)
K942116 · KPS
Siemens Corp.
Radiology · 87d
Cleared Jul 29, 1994
AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS
K942158 · EPP
Wfr/Aquaplast Corp.
Ear, Nose, Throat · 87d
Cleared Jul 29, 1994
COMFEEL PLUS TRANSPARENT DRESSING
K942283 · KMF
Richard Hamer Assoc., Inc.
General & Plastic Surgery · 79d
Cleared Jul 29, 1994
FUJI ULTIMA EC-MA CASSETTE
K942481 · IXA
Fujifilm Medical System U.S.A., Inc.
Radiology · 65d
Cleared Jul 29, 1994
ANGIOREST TABLE PAD SYSTEM
K942674 · JAA
Scribner Browne Medical Design, Inc.
Radiology · 53d
Cleared Jul 29, 1994
MODEL VPW2877F8, MAMMO 5 POWER SUPPLY
K942778 · IZO
Varian Assoc., Inc.
Radiology · 46d
Cleared Jul 29, 1994
BUCKY STAND BR-10M
K942792 · KPR
Shimadzu Corp.
Radiology · 45d
Cleared Jul 29, 1994
KYOKKO BLUE SERIES INTENSIFYING SCREENS
K942805 · EAM
Fujifilm Medical System U.S.A., Inc.
Radiology · 44d
Cleared Jul 29, 1994
KODAK INSIGHT TWIN-LOAD INSERT
K942909 · EAM
Eastman Kodak Company
Radiology · 38d
Cleared Jul 29, 1994
SKIN STAPLE REMOVAL TRAYS
K943046 · MCZ
Sterile Concepts, Inc.
General & Plastic Surgery · 32d
Cleared Jul 29, 1994
TRU-CORE NEEDLE SET
K943368 · KNW
Ideamatrix
Gastroenterology & Urology · 16d
Cleared Jul 28, 1994
IRIS G-PROBE
K915236 · GEX
Iriderm Div.
General & Plastic Surgery · 979d
Cleared Jul 28, 1994
SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPS
K930773 · HFB
Symbiosis Corp.
Obstetrics & Gynecology · 527d
Cleared Jul 28, 1994
ONE-SITE IV CONNECTOR
K932789 · FOZ
Care Medical Devices, Inc.
General Hospital · 414d