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
103201–103224 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 26, 1995
ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY
K943873 · LXH
Orthomet, Inc.
Orthopedic · 260d
Cleared Apr 26, 1995
NEW-STIM SPINAL ADJUSTMENT INSTRUMENT
K944369 · LXM
Lawrence E. Newsum, DC
Physical Medicine · 231d
Cleared Apr 26, 1995
THE BREATHER
K944412 · BWF
Pal Medical, Inc.
Anesthesiology · 230d
Cleared Apr 26, 1995
KIS-II STR FIXTURES
K944725 · DZE
Implant Center of the Palm Beaches
Dental · 212d
Cleared Apr 26, 1995
ZIMMER MONOBLOC HIP PROSTHESIS WITH POLY (METHYL METHACRYLATE)
K944792 · JDI
Zimmer, Inc.
Orthopedic · 210d
Cleared Apr 26, 1995
NOPROFILE OLBERT CATHETER SYSTEM
K944989 · LIT
Meadox Medicals, Div. Boston...
Cardiovascular · 196d
Cleared Apr 26, 1995
SELBY INSTRUMENTATION
K945064 · MNH
Advanced Spine Fixation Systems, Inc.
Orthopedic · 194d
Cleared Apr 26, 1995
577ES (ERGOSENSE)
K945257 · INO
Lumex, Inc.
Physical Medicine · 180d
Cleared Apr 26, 1995
CORDIS INTRODUCING CATHETER
K945524 · DYB
Cordis Corp.
Cardiovascular · 167d
Cleared Apr 26, 1995
ACUFEX TAG(R) BIOABSORBABLE ANCHORS
K946346 · JDR
Acufex Microsurgical, Inc.
Orthopedic · 117d
Cleared Apr 26, 1995
IV SHUTTLE
K950367 · FOX
Equipment Concepts, Inc.
General Hospital · 85d
Cleared Apr 26, 1995
X2000 TRADITIONAL WHEELCHAIR
K951351 · IOR
Homecrest Industries
Physical Medicine · 34d
Cleared Apr 25, 1995
HYDROGEN SPECTROSCOPY OPTION-PROBE #M1040HS/HT
K930265 · LNI
GE Medical Systems
Radiology · 826d
Cleared Apr 25, 1995
COLPOSCOPES AND ACCESSORIES
K940094 · HEX
Leisegang Medical, Inc.
Obstetrics & Gynecology · 473d
Cleared Apr 25, 1995
CLARUS PHOENIX ENDOSCOPE
K940144 · HRX
Clarus Medical Systems, Inc.
Orthopedic · 469d
Cleared Apr 25, 1995
CLARUS NEURO ENDOSCOPE (MODEL 2230)
K941188 · HRX
Clarus Medical Systems, Inc.
Orthopedic · 407d
Cleared Apr 25, 1995
EZ-RANGE
K941965 · JPK
Hematronix, Inc.
Hematology · 368d
Cleared Apr 25, 1995
AESCULAP LAPAROSCOPES
K942730 · HET
Aesculap, Inc.
Obstetrics & Gynecology · 320d
Cleared Apr 25, 1995
ACCUCURE 3000
K943411 · GEX
Lasermed
General & Plastic Surgery · 285d
Cleared Apr 25, 1995
NATURAL RUBBER LATEX SURGEONS GLOVE
K944053 · KGO
Arent Fox
General Hospital · 249d
Cleared Apr 25, 1995
OREX ISOLATION GOWN
K945223 · FYC
Thantex Specialties, Inc.
General Hospital · 181d
Cleared Apr 25, 1995
LUNAR EXPERT
K945526 · KGI
Lunar Corp.
Radiology · 166d
Cleared Apr 25, 1995
PROSHIELD PLUS MULTIPLE
K946111 · LYY
Sino (U.S.A.) Co.
General Hospital · 131d
Cleared Apr 25, 1995
SSCOR/BOARD ..3 MODEL 23000 PRE-ASSEMBLED SUCTION SYSTEM FOR PATIENT...
K950464 · GCX
Sscor
General Hospital · 81d