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
100873–100896 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 19, 1995
NEURO CHANNEL ENDOSCOPE MODEL 2232
K945633 · GWG
Clarus Medical Systems, Inc.
Neurology · 307d
Cleared Sep 19, 1995
GYRES 2T PRESTIGE
K945791 · LNH
Elscint, Inc.
Radiology · 298d
Cleared Sep 19, 1995
SLEEP TEST(TM)
K950273 · MNR
Cns, Inc.
Anesthesiology · 239d
Cleared Sep 19, 1995
STOMAVISION (STV)
K951074 · EIA
Trophy Radiologie
Dental · 194d
Cleared Sep 19, 1995
STRYKER INTERPULSE HANDPIECE SET, IRRIGATION TIPS, SPLASH SHIELDS, CANAL...
K951666 · FQH
Stryker Instruments
General Hospital · 162d
Cleared Sep 19, 1995
ETHYLENE OXIDE STERILIZATION OF POLYETHYLENE ORTHOPEDIC DEVICES
K952068 · HSX
Zimmer, Inc.
Orthopedic · 140d
Cleared Sep 19, 1995
CLARITY SYSTEM II
K952080 · GWJ
Sonamed Corp.
Neurology · 139d
Cleared Sep 19, 1995
LIFE SOUND SENSOR
K952651 · DQC
Flowscan, Inc.
Cardiovascular · 102d
Cleared Sep 19, 1995
BUCHALTER FAUSER FEMORAL COMPONENTS
K952686 · LZO
Biomet, Inc.
Orthopedic · 99d
Cleared Sep 19, 1995
MEDICAL MIXTURE-LUNG DIFFUSION GAS MIXTURES
K952838 · BXK
Standard Welders Supply Co.
Anesthesiology · 92d
Cleared Sep 19, 1995
LOW PROFILE TITANIUM MODEL CATALOG #1003
K953073 · LJT
Arrow Intl., Inc.
General Hospital · 81d
Cleared Sep 19, 1995
SCIMED TRIGUIDE GUIDE CATHETERS
K953515 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 55d
Cleared Sep 19, 1995
LAPAROSCOPIC SURGICAL INSTRUMENT
K953548 · HET
Gabris Surgical Corp.
Obstetrics & Gynecology · 53d
Cleared Sep 19, 1995
UNICOR, INC. CORRUGATED TUBING
K953784 · BZO
Unicor, Inc.
Anesthesiology · 36d
Cleared Sep 19, 1995
UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS
K953786 · BZA
Unicor, Inc.
Anesthesiology · 36d
Cleared Sep 19, 1995
UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT
K953787 · CAI
Unicor, Inc.
Anesthesiology · 36d
Cleared Sep 19, 1995
UNICOR, INC. GAS SAMPLING LINES & CONNECTORS
K953788 · CAI
Unicor, Inc.
Anesthesiology · 36d
Cleared Sep 19, 1995
LIFEMASK FACE SHIELD
K953824 · BTM
Carefree Trading, Inc.
Anesthesiology · 35d
Cleared Sep 19, 1995
WILSON-COOK TRIPLE LUMEN BALLOON STONE EXTRACTOR
K953951 · GCA
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 28d
Cleared Sep 18, 1995
UHMWPE COMPONENTS-CHANGE IN PACKAGING
K940743 · KWY
Depuy, Inc.
Orthopedic · 579d
Cleared Sep 18, 1995
PCA(R) MODULAR TOTAL KNEE TIB INSERT DUROCON BASEPLATE
K940861 · JWH
Howmedica Corp.
Orthopedic · 572d
Cleared Sep 18, 1995
LP-12 LAPAROSCOPIC PROBE
K941935 · ITX
Biosound, Inc.
Radiology · 516d
Cleared Sep 18, 1995
A620 EEG
K944615 · HCC
Stoelting Co.
Neurology · 363d
Cleared Sep 18, 1995
OUTLOOK
K945827 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 293d