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
104569–104592 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 01, 1995
PHILIPS IMPROVED CHECK RADIOGRAPH OPTION
K943464 · IYE
Philips Medical Systems North...
Radiology · 198d
Cleared Feb 01, 1995
ARTHREX STAPLES
K943492 · JDR
Arthrex, Inc.
Orthopedic · 197d
Cleared Feb 01, 1995
CLINICAL BLOOD GAS MIXTURE
K944812 · BXK
Laboratory & Specialty Gases, Inc.
Anesthesiology · 125d
Cleared Feb 01, 1995
INNOVASIVE 1.9MM, 2.8MM, 3.5MM, 4.5MM ROC SUTURE BONE FASTENER
K944831 · MBI
Innovasive Devices, Inc.
Orthopedic · 125d
Cleared Feb 01, 1995
CONSENUS HIP SYSTEM FEMORAL CANAL STARTER REAMER
K944946 · HWE
U.S. Medical Products, Inc.
Orthopedic · 117d
Cleared Feb 01, 1995
TROCHANTER MESH
K945027 · EZX
Acu Med, Inc.
General & Plastic Surgery · 111d
Cleared Feb 01, 1995
PEDIATRIC OSTEOTOMY SYSTEM
K945233 · KTT
Howmedica Corp.
Orthopedic · 121d
Cleared Feb 01, 1995
BLOOD KIT, SEXUAL ASSAULT KIT
K945245 · JKA
Lynn Peavey Co.
Toxicology · 97d
Cleared Feb 01, 1995
NEZHAT-DORSEY (TM) ELECTROSHIELD(TM) PROBES AND ACCESSORIES
K945317 · GEI
American Hydro-Surgical Instruments,...
General & Plastic Surgery · 92d
Cleared Feb 01, 1995
FUKUDA DENSHI MODE HG-302 PULSE OXIMETER MODULE
K945464 · DQA
Fukuda Denshi USA, Inc.
Anesthesiology · 86d
Cleared Feb 01, 1995
SERIM(TM) BICARB PH REAGENT STRIPS
K945491 · MNV
Serim Research Corp.
Gastroenterology & Urology · 85d
Cleared Feb 01, 1995
SUNGLASSES AND SPORT SUNGLASSES
K945528 · HQY
Lily & Assoicates, Inc.
Ophthalmic · 79d
Cleared Feb 01, 1995
TRANS X-1000
K945635 · KPX
Canon USA, Inc.
Radiology · 77d
Cleared Feb 01, 1995
ECHO STAR NEEDLE SET
K945921 · FCG
Ideamatrix
Gastroenterology & Urology · 58d
Cleared Feb 01, 1995
CAD ON WHEELS
K946079 · IOR
Rehab 'N Motion Technologies
Physical Medicine · 50d
Cleared Feb 01, 1995
REGAIN STAND-UP WHEELCHAIR
K946110 · IPL
Regain, Inc.
Physical Medicine · 49d
Cleared Feb 01, 1995
CONMED SOFT-TIP SUCTION/IRRIGATION CANNULAE
K950170 · GCJ
Conmedcorp
General & Plastic Surgery · 15d
Cleared Feb 01, 1995
LAPAROSCOPE AND ACCESSORIES FOR GENERAL SURGERY
K950231 · GCJ
Olympus America, Inc.
General & Plastic Surgery · 23d
Cleared Feb 01, 1995
VASOTRAC BLOOD PRESSURE MONITOR, MODEL - APM 205
K950249 · DXN
Medwave, Inc.
Cardiovascular · 12d
Cleared Feb 01, 1995
MINI LAPAROSCOPY FOR GENERAL SURGERY
K950278 · GCJ
Olympus America, Inc.
General & Plastic Surgery · 8d
Cleared Jan 31, 1995
RELAXOMAT
K925750 · HCC
Relaxomat, Inc.
Neurology · 809d
Cleared Jan 31, 1995
ALPHA STEREO
K934478 · IZH
Instrumentarium Corp.
Radiology · 504d
Cleared Jan 31, 1995
DURALASTIC SHEETING
K935571 · MIB
Applied Biomaterial Technologies
General & Plastic Surgery · 439d
Cleared Jan 31, 1995
SAFE-1(TM) SYRINGE
K940635 · FMF
Safety 1st Medical, Inc.
General Hospital · 351d