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
87841–87864 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 04, 1998
RUSCH POLYFLEX STENT KIT
K982614 · NYT
Rusch Intl.
General & Plastic Surgery · 130d
Cleared Dec 04, 1998
G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER)
K982812 · KWY
Johnson & Johnson Professionals, Inc.
Orthopedic · 115d
Cleared Dec 04, 1998
PRE-POWDERED NON-STERILE SYNTHETIC EXAMINATION GLOVE
K982885 · LYZ
Shanghai Poseidon Plastic Products...
General Hospital · 109d
Cleared Dec 04, 1998
ACCUTRAX, MODEL EPF840
K982995 · BZH
Korr Medical Technologies, Inc.
Anesthesiology · 99d
Cleared Dec 04, 1998
DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1)
K983129 · KYB
Staar Surgical Co.
Ophthalmic · 87d
Cleared Dec 04, 1998
NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTS
K983153 · JWH
Sulzer Orthopedics, Inc.
Orthopedic · 86d
Cleared Dec 04, 1998
MULTIPULSE CO2 LASER
K983215 · GEX
Aesculap-Meditec GmbH
General & Plastic Surgery · 81d
Cleared Dec 04, 1998
OSTEONICS X CEMENTED HIP STEM SERIES
K983226 · JDI
Osteonics Corp.
Orthopedic · 80d
Cleared Dec 04, 1998
BIPOLAR HF CABLE
K983236 · GEI
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 80d
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