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
87337–87360 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 04, 1998
STEALTHSTATION TREATMENT GUIDANCE PLAFFORM
K983397 · HAW
Surgical Navigation Technologies, Inc.
Neurology · 70d
Cleared Dec 04, 1998
HOLLAND FEMORAL NAIL SYSTEM
K983641 · HSB
Biomet, Inc.
Orthopedic · 49d
Cleared Dec 04, 1998
SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES
K983645 · LYZ
Shijiazhuang Great Eagle Plastic...
General Hospital · 49d
Cleared Dec 04, 1998
BONE BAND
K983685 · LYT
Chapel and Assoc.
Orthopedic · 45d
Cleared Dec 04, 1998
SYNTEC-TAICHUNG NON-STERILE KNOWLES PIN, MODELS: FOR HEXAGONAL COLLAR:...
K983757 · JDW
Syntec Scientific Corp.
Orthopedic · 42d
Cleared Dec 04, 1998
NITRILE LATEX POWDERED EXAMINATION GLOVE
K983816 · LZA
Top Glove Sdn. Bhd.
General Hospital · 36d
Cleared Dec 04, 1998
NITRILE LATEX POWDER FREE EXAMINATION GLOVE
K983825 · LZA
Top Glove Sdn. Bhd.
General Hospital · 36d
Cleared Dec 04, 1998
COBRA EXTERNAL FIXATOR
K983881 · HRS
Orthopaedic Innovations, Inc.
Orthopedic · 32d
Cleared Dec 04, 1998
THERATRON ELITE
K983917 · IWB
Theratronics, Inc.
Radiology · 30d
Cleared Dec 04, 1998
INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAP
K983942 · JDS
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Dec 04, 1998
AMERSE 2
K983947 · LRJ
STERIS Corporation
General Hospital · 29d
Cleared Dec 04, 1998
QUADRANT UNIVERSAL LC
K984041 · EBF
Cavex Holland BV
Dental · 21d
Cleared Dec 04, 1998
QUADRANT CORE LC
K984042 · EBF
Cavex Holland BV
Dental · 21d
Cleared Dec 04, 1998
QUADRANT TOTAL ETCH
K984043 · EBF
Cavex Holland BV
Dental · 21d
Cleared Dec 03, 1998
MONITOR ONE NDX
K972991 · DPS
Qmed, Inc.
Cardiovascular · 478d
Cleared Dec 03, 1998
PREMIER CRYPTOSPORIDIUM
K982764 · MHJ
Meridian Diagnostics, Inc.
Microbiology · 119d
Cleared Dec 03, 1998
ELECTROSURGICAL INFLATABLE BASKET ELECTRODES
K983116 · GEI
Conway Stuart Medical, Inc.
General & Plastic Surgery · 90d
Cleared Dec 03, 1998
IMPLEX HEDROCEL REPLACEMENT CUP INSERT MODEL NUMBERS 02-246-XXYYY,...
K983128 · JDI
Implex Corp.
Orthopedic · 86d
Cleared Dec 03, 1998
OSTEO 4.0MM CANNULATED SCREW SYSTEM
K983165 · HWC
Osteonics Corp.
Orthopedic · 84d
Cleared Dec 03, 1998
NELSON RESURFACING HEAD
K983452 · KXA
Biomet, Inc.
Orthopedic · 64d
Cleared Dec 03, 1998
DEPUY ACROMED MOSS AND MOSS MIAMI SPINAL SYSTEMS
K983583 · KWP
Depuy, Inc.
Orthopedic · 51d
Cleared Dec 03, 1998
LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644
K984071 · JJX
Bio-Rad
Chemistry · 17d
Cleared Dec 02, 1998
ERADIC-ALL
K981171 · EIA
Theratechnologies, Inc.
Dental · 245d
Cleared Dec 02, 1998
DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF...
K981881 · DZL
Doctor'S Research Group, Inc.
Dental · 188d