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
91297–91320 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 14, 1997
SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER
K972109 · FZW
General Surgical Innovations
General & Plastic Surgery · 162d
Cleared Nov 14, 1997
RASCAL POWER CHAIR
K972370 · ITI
Electric Mobility Corp.
Physical Medicine · 142d
Cleared Nov 14, 1997
MOST HEX INTRAMEDULLARY (I/M) STEM
K973087 · LZO
Sulzer Orthopedics, Inc.
Orthopedic · 88d
Cleared Nov 14, 1997
NPB-295 PULSE OXIMETER
K973147 · DQA
Nellcor Puritan Bennett, Inc.
Anesthesiology · 84d
Cleared Nov 14, 1997
AMERICAN DENTAL PRODUCTS HB-35 DESENSITIZER WITH FLUORIDE
K973185 · KLE
American Dental Products, Inc.
Dental · 81d
Cleared Nov 14, 1997
SYNTEC TRUE LIGHT ENDOILLUMIINATOR WITH PICK
K973290 · MPA
Vaughan Weeks
Ophthalmic · 73d
Cleared Nov 14, 1997
PASCO MIC AND MIC/ID PANELS
K973317 · LTT
Pasco Laboratories, Inc.
Microbiology · 72d
Cleared Nov 14, 1997
SENSOR PAD
K973450 · IYO
Inventive Products, Inc.
Radiology · 64d
Cleared Nov 13, 1997
TED 191
K963177 · CCL
Teledyne Brown Engineering
Anesthesiology · 456d
Cleared Nov 13, 1997
IMAGING JET SYSTEM
K970782 · JAB
General Robotic Devices, Inc.
Radiology · 254d
Cleared Nov 13, 1997
ATOMISOR
K970844 · CAF
Medical Consulting Service, Inc.
Anesthesiology · 251d
Cleared Nov 13, 1997
SERODIA TP-PA
K971502 · GMT
Scimedx Tekfile Services
Microbiology · 203d
Cleared Nov 13, 1997
IMPACT (INFORMING MOBILE PERSONNEL AND CARE TRACKING) PAGER SYSTEM
K971868 · MSX
Marquette Electronics, Inc.
Cardiovascular · 177d
Cleared Nov 13, 1997
SNT LINAC ACCESSORIES
K971893 · IYE
Surgical Navigation Technologies, Inc.
Radiology · 175d
Cleared Nov 13, 1997
CARR RIGID CONTAINER SYSTEM
K972138 · FRG
Carr Metal Products, Inc.
General Hospital · 160d
Cleared Nov 13, 1997
FLUID MANAGEMENT SYSTEM
K972284 · FRN
Belmont Instrument Corp.
General Hospital · 147d
Cleared Nov 13, 1997
PEDO CUSH PEDO CUDDLE
K972446 · FMQ
Cavity Free Kids, Inc.
General Hospital · 136d
Cleared Nov 13, 1997
PIVOTAL SCISSOR
K972510 · GEI
Urohealth Systems, Inc.
General & Plastic Surgery · 133d
Cleared Nov 13, 1997
LANG DENTAL RESIN A97 FIBRED PINK
K972553 · EBI
Lang Dental Mfg. Co., Inc.
Dental · 128d
Cleared Nov 13, 1997
OPTI-MAX ANGLED CROWN POST FOR EXTERNALLY-HEXED IMPLANTS, IN 15 DEGREE AND 25...
K972769 · DZE
Opti-Max
Dental · 112d
Cleared Nov 13, 1997
PLUS EPF ACETABULAR CUP
K972931 · LWJ
Hhl Consulting
Orthopedic · 97d
Cleared Nov 13, 1997
IMCOR EXTERNALLY HEXED, SELF-TAPPING SCREW IMPLANT SURGICAL DRILLING SYSTEM
K973049 · DZE
Imcor
Dental · 90d
Cleared Nov 13, 1997
REALVIEW TELEMEDICINE SYSTEM
K973065 · LLZ
Vcom Systems, Inc.
Radiology · 87d
Cleared Nov 13, 1997
PLUS-FIT ACETABULAR CUP
K973077 · LWJ
Plus Orthopedics
Orthopedic · 87d