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
79609–79632 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 15, 2001
SMITH & NEPHEW SUTURE ANCHOR
K003599 · HWC
Smith & Nephew, Inc.
Orthopedic · 86d
Cleared Feb 15, 2001
ONYX-RAD TELEMEDICINE PACS
K003607 · LLZ
Viztek, Inc.
Radiology · 85d
Cleared Feb 15, 2001
PERMLASTIC 3
K003650 · ELW
Sybron Dental Specialties, Inc.
Dental · 80d
Cleared Feb 15, 2001
ACCUFUSER
K003915 · MEB
Help Technologies
General Hospital · 58d
Cleared Feb 15, 2001
NITRILE EXAMINATION GLOVES (POWERED)
K003922 · LZA
Guthrie Medicare Products (Melaka)...
General Hospital · 57d
Cleared Feb 15, 2001
DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D...
K003977 · FPA
Disetronic Medical Systems AG
General Hospital · 55d
Cleared Feb 15, 2001
ANA EIA DIAGNOSTIC TEST KIT
K004019 · LJM
The Binding Site, Ltd.
Immunology · 50d
Cleared Feb 15, 2001
PERFECTA AND EXTEND
K004032 · LPH
Wrightmedicaltechnologyinc
Orthopedic · 49d
Cleared Feb 15, 2001
DURABOND NON-PRECIOUS CERAMIC ALLOY
K010069 · EJH
Matech, Inc.
Dental · 38d
Cleared Feb 15, 2001
A & I WHEELCHAIRS
K010094 · IOR
Taiwan an I Co., Ltd.
Physical Medicine · 35d
Cleared Feb 15, 2001
COMFOR-CLINER
K010194 · IOR
Recliner Care, Inc.
Physical Medicine · 24d
Cleared Feb 15, 2001
STERILE NITRILE POWDER-FREE EXAMINATION GLOVES
K010211 · LZC
Allegiance Healthcare Corp.
General Hospital · 23d
Cleared Feb 15, 2001
TRI-FIT FEMORAL STEM
K010243 · LWJ
Corin USA
Orthopedic · 21d
Cleared Feb 14, 2001
INTRAVASCULAR IV SET, IV SET WITH BURETTE, EXTENSION SET
K001329 · FPA
Lifemed of California
General Hospital · 293d
Cleared Feb 14, 2001
SYNTRA DIALYZER, MODEL SYNTRA 120, 160
K002210 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 208d
Cleared Feb 14, 2001
RCRP FLEX REAGENT CARTRIDGE
K003419 · DCN
Dade Behring, Inc.
Immunology · 104d
Cleared Feb 14, 2001
COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS
K003566 · KWS
Smith & Nephew, Inc.
Orthopedic · 86d
Cleared Feb 14, 2001
TENSCARE, MODEL TENS XL-2
K003591 · GZJ
Tenscare, Ltd.
Neurology · 85d
Cleared Feb 14, 2001
DELFIA NEONATAL IRT KIT, MODEL A005-110
K003664 · CGZ
Wallac OY
Chemistry · 78d
Cleared Feb 14, 2001
REVEAL PLUS INSERTABLE LOOP RECORDER
K003667 · MXC
Medtronic Vascular
Cardiovascular · 78d
Cleared Feb 14, 2001
MICROSCOPE-STAINLESS STEEL/FIBER OPTIC: .5-2.6MM MODEL MMD 4500 SERIES AND...
K003695 · HRX
Micro-Medical Devices, Inc.
Orthopedic · 76d
Cleared Feb 14, 2001
TITANIUM CEMENT RESTRICTOR (TCR)
K003718 · JDK
Medtronic Sofamor Danek, Inc.
Orthopedic · 72d
Cleared Feb 14, 2001
CONSTELLATION CATHETER, MODEL 8031
K003782 · MTD
Boston Scientific Corp
Cardiovascular · 69d
Cleared Feb 14, 2001
BIOLUCENT MAMMOGRAPHY CUSHION
K003795 · IZH
Biolucent, Inc.
Radiology · 68d