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
86113–86136 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 03, 1999
UNI-CLIP STAPLE
K991482 · JDR
New Deal, S.A.
Orthopedic · 36d
Cleared Jun 03, 1999
POWDERED NITRILE EXAMINATION GLOVE, WHITE (NON-COLORED)
K991511 · LZA
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 34d
Cleared Jun 03, 1999
OPERA CUPFLANGED ACETABULAR COMPONENTS
K991538 · JDI
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 31d
Cleared Jun 03, 1999
SMARTSPOT 2000
K991578 · LLZ
Cmt Medical Technologies, Ltd.
Radiology · 28d
Cleared Jun 03, 1999
SOFTINJECT
K991680 · KZH
Androsystems Srl
General Hospital · 17d
Cleared Jun 03, 1999
SSA-370A/POWERVISION 6000
K991710 · IYO
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Jun 02, 1999
AILEE SUTURES AND AILEE NEEDLES
K982646 · GAL
Myco Medical Supplies, Inc.
General & Plastic Surgery · 308d
Cleared Jun 02, 1999
INTRACOIL PERIPHERAL STENT
K990221 · JCT
Intratherapeutics, Inc.
General & Plastic Surgery · 131d
Cleared Jun 02, 1999
THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY
K990658 · JLW
Little Nell Labs, Inc.
Chemistry · 93d
Cleared Jun 02, 1999
FIXION INTRAMEDULLARY NAILING SYSTEM
K990717 · HSB
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 90d
Cleared Jun 02, 1999
OSTEONICS SPINAL SYSTEM VERSATILE CROSS CONNECTOR
K990922 · KWP
Howmedica Osteonics Corp.
Orthopedic · 75d
Cleared Jun 02, 1999
GENERAL PURPOSE NEOFLEX TRANSDUCER COVER, EDOCAVITY NEOFLEX TRANSDUCER COVER,...
K991236 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 51d
Cleared Jun 02, 1999
TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005
K991311 · CDP
Biocheck, Inc.
Chemistry · 47d
Cleared Jun 02, 1999
BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007
K991432 · KLI
Biocheck, Inc.
Chemistry · 37d
Cleared Jun 02, 1999
SYNTHES PEDIATRIC ROD SYSTEM
K991552 · MNH
Synthes (Usa)
Orthopedic · 30d
Cleared Jun 01, 1999
AVOGEL
K981353 · MDA
Avocet Polymer Technologies, Inc.
General & Plastic Surgery · 413d
Cleared Jun 01, 1999
MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000
K982889 · BYI
Electromed, Inc.
Anesthesiology · 288d
Cleared Jun 01, 1999
IMPLEX RADIAL HEAD REPLACEMENT SYSTEM
K984290 · KWI
Implex Corp.
Orthopedic · 182d
Cleared Jun 01, 1999
VITAL PEP
K984468 · BWF
Vital Signs, Inc.
Anesthesiology · 167d
Cleared Jun 01, 1999
KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM
K990154 · FWF
Karl Storz Imaging, Inc.
General & Plastic Surgery · 133d
Cleared Jun 01, 1999
ALPHAMED GEMINI SENSOR, SNORING SENSOR
K990321 · MNR
Alphamed, Inc.
Anesthesiology · 120d
Cleared Jun 01, 1999
BONE SCREWS
K990351 · HWC
Bregma International Trading Company...
Orthopedic · 116d
Cleared Jun 01, 1999
STAINLESS STEEL FIXATION PINS
K990353 · JDW
Bregma International Trading Company...
Orthopedic · 116d
Cleared Jun 01, 1999
COOPERSURGICAL COAGULATOR FOR TATTOO REMOVAL
K990850 · KNS
CooperSurgical, Inc.
Gastroenterology & Urology · 78d