FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
80233–80256 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 05, 2001
MODULAR
K001988 · BSZ
Heyer America, Inc.
Anesthesiology · 221d
Cleared Feb 05, 2001
ELECTROSTATIC HYDROPHOBIC BREATHING FILTER
K002201 · CAH
Sims Portex, Inc.
General Hospital · 200d
Cleared Feb 05, 2001
PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602
K002280 · MKJ
Medical Devices, Inc.
Cardiovascular · 194d
Cleared Feb 05, 2001
RANDOX TRANSFERRIN
K002585 · DDG
Randox Laboratories, Ltd.
Chemistry · 168d
Cleared Feb 05, 2001
MINIQUANT D-DIMER, MODEL 1447
K002642 · DAP
Biopool Intl., Inc.
Hematology · 165d
Cleared Feb 05, 2001
MICTEC ENDOSCOPES AND ACCESSORIES
K002877 · GEI
Dufner Instrumente GmbH
General & Plastic Surgery · 143d
Cleared Feb 05, 2001
TRIOLOGY ACETABULAR SYSTEM 46MM LARGE HEAD LINERS, MODEL 6310
K003478 · LPH
Zimmer, Inc.
Orthopedic · 88d
Cleared Feb 05, 2001
IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2
K003597 · LPS
Diagnostic Products Corp.
Toxicology · 76d
Cleared Feb 05, 2001
OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT PULSE OXIMETRY...
K003704 · BZQ
Optovent AB
Anesthesiology · 66d
Cleared Feb 05, 2001
ADVIA 120 HEMATOLOGY
K003796 · GKZ
Bayer Corp.
Hematology · 59d
Cleared Feb 05, 2001
INTRAVASCULAR ADMINISTRATION SET
K003854 · FPA
Infusion Devices, Inc.
General Hospital · 54d
Cleared Feb 05, 2001
LIVESURE THC SCREEN TEST
K010001 · LDJ
Pan Probe Biotech, Inc.
Toxicology · 34d
Cleared Feb 05, 2001
ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY
K010050 · CGN
Bayer Diagnostics Corp.
Chemistry · 31d
Cleared Feb 05, 2001
ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS
K010081 · KWY
Exactech, Inc.
Orthopedic · 26d
Cleared Feb 05, 2001
MULTI INTERFERENTIAL STIMULATOR, MODEL TR-841
K993600 · LIH
Nisha Communication Industries
Neurology · 469d
Cleared Feb 02, 2001
SAFE-POINT VAC, SAFE-POINT M-D BLOOD COLLECTION SYSTEMS
K001965 · FMI
North American Medical Products, Inc.
General Hospital · 219d
Cleared Feb 02, 2001
ACE SDS 3.75MM SCREW DENTAL IMPLANT
K002075 · DZE
Ace Surgical Supply Co., Inc.
Dental · 207d
Cleared Feb 02, 2001
WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE
K002219 · GXY
Wandy Rubber Industrial Co., Ltd.
Neurology · 193d
Cleared Feb 02, 2001
WANDY SILICONE CONDUCTIVE RUBBER PAD
K002227 · GXY
Wandy Rubber Industrial Co., Ltd.
Neurology · 193d
Cleared Feb 02, 2001
P3IMRT TM
K002237 · MUJ
Adac Laboratories
Radiology · 193d
Cleared Feb 02, 2001
EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZER
K002407 · JGS
Medica Corp.
Chemistry · 179d
Cleared Feb 02, 2001
SELECT SEED I-125
K002429 · KXK
Nucletron Corp.
Radiology · 178d
Cleared Feb 02, 2001
SURGI-VISION GUIDEWIRE COIL
K003436 · MOS
Surgi-Vision, Inc.
Radiology · 88d
Cleared Feb 02, 2001
ODYSSEY LX, MODEL 211320
K003437 · LLZ
Philips Medical Systems (Cleveland),...
Radiology · 88d