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
106993–107016 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 09, 1994
ARTICULATED, LAPAROSCOPIC, AND SIDE-VIEWING T-PROBES
K935157 · KPX
Regulatory Consultants TO the Medical...
Radiology · 285d
Cleared Aug 09, 1994
PERCOR STAT-DL 9.5 FR.34CC & 40CC /PERCOR STAT-DL 10.5 FR.40CC & 50CC...
K940178 · DSP
Datascope Corp.
Cardiovascular · 209d
Cleared Aug 09, 1994
SIMON NITINOL FILTER
K940489 · DTK
Nitinol Medical Technologies, Inc.
Cardiovascular · 196d
Cleared Aug 09, 1994
STARKEY CE-8 TML, STARKEY CE-8 TMC AIR CONDUCTION HEARING AID
K940667 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 174d
Cleared Aug 09, 1994
THE CANAL (C.I.C.) AKA/HIDDEN EAR
K941107 · ESD
Qualitone, Inc.
Ear, Nose, Throat · 155d
Cleared Aug 09, 1994
DUPONT ACA PLUS FSH/LH/PROLACTIN CALIBRATOR
K941219 · JIX
Dupont Medical Products
Chemistry · 148d
Cleared Aug 09, 1994
WATER IRRIGATOR, W1 200
K941325 · KHH
Strong Medical, Inc.
Ear, Nose, Throat · 144d
Cleared Aug 09, 1994
CRYSTAL EAR
K942189 · ESD
Crystal Care Intl., Inc.
Ear, Nose, Throat · 97d
Cleared Aug 09, 1994
ACI SILICATH THORACIC CATHETER
K942335 · GBX
American Catheter
General & Plastic Surgery · 85d
Cleared Aug 09, 1994
OEC 901
K942841 · JAA
Baldwin
Radiology · 54d
Cleared Aug 09, 1994
STANDUP WHEELCHAIR
K943337 · IPL
Nestor Rehab Products , Ltd.
Physical Medicine · 28d
Cleared Aug 09, 1994
LASER ALIGNMENT TOOL
K943381 · IWE
Philips Medical Systems North...
Radiology · 27d
Cleared Aug 09, 1994
PHILIPS M38 SERIES
K943395 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 26d
Cleared Aug 09, 1994
DISPOSABLE SURGICAL TROCAR
K943489 · GCJ
Applied Medical Resources
General & Plastic Surgery · 21d
Cleared Aug 09, 1994
GSI CANNULA REDUCER ACCESSORY
K943671 · GCJ
General Surgical Innovations
General & Plastic Surgery · 14d
Cleared Aug 08, 1994
OCEANIA HEALTH CARE SYSTEMS ELECTRONIC MEDICAL REC
K921846 · LNX
Oceania Health Care Systems, Inc.
General Hospital · 843d
Cleared Aug 08, 1994
BRANEMARK SYSTEM(R) UCLA-TYPE ABUTMENT COMPLETE
K934495 · DZE
Nobelpharma AB
Dental · 328d
Cleared Aug 08, 1994
BRANEMARK SYSTEM
K934825 · DZE
Nobelpharma USA, Inc.
Dental · 304d
Cleared Aug 08, 1994
BRANEMARK-HEALING CAPS, DCC045, DCC046, DCC104
K934826 · DZE
Nobelpharma USA, Inc.
Dental · 304d
Cleared Aug 08, 1994
BRANEMARK SYSTEM ESTHETICONE NON-ROTATIONAL SYSTEM
K934827 · DZE
Nobelpharma USA, Inc.
Dental · 304d
Cleared Aug 08, 1994
AUTOCLAVEABLE MEDICAM 900 DIGICON CAMERA
K942358 · GCJ
M.P. Video, Inc.
General & Plastic Surgery · 83d
Cleared Aug 08, 1994
IMPLANTECH MIDFACE-SUBMALAR LE FORT IMPLANT
K942420 · LZK
King & Spalding
General & Plastic Surgery · 80d
Cleared Aug 08, 1994
IMPLANTECH LATERAL MANDIBULAR BAR IMPLANT
K942421 · LZK
King & Spalding
General & Plastic Surgery · 80d
Cleared Aug 08, 1994
AFP CARDIAC PACING SYSTEM MODEL 283
K942440 · DTB
Siemens-Pacesetter, Inc.
Cardiovascular · 80d