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
105433–105456 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 05, 1994
SUTULENE
K943220 · GAT
Sutures , Ltd.
General & Plastic Surgery · 153d
Cleared Dec 05, 1994
SURGIBOND
K943221 · GAT
Sutures , Ltd.
General & Plastic Surgery · 153d
Cleared Dec 05, 1994
SURGIDEK S
K943222 · GAR
Sutures , Ltd.
General & Plastic Surgery · 153d
Cleared Dec 05, 1994
SURGIDEK B
K943223 · GAR
Sutures , Ltd.
General & Plastic Surgery · 153d
Cleared Dec 05, 1994
SURFACE TEMPERATURE PROBES
K943270 · FLL
Coast Medical, Inc.
General Hospital · 151d
Cleared Dec 05, 1994
MEGABEAM LATERAL FIRE
K943527 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 137d
Cleared Dec 05, 1994
SURGISILK
K943627 · GAP
Sutures , Ltd.
General & Plastic Surgery · 132d
Cleared Dec 05, 1994
SURE-FLO IRRIGATION Y TUBING SET
K944119 · JCX
O.R. Resources, Inc.
General & Plastic Surgery · 104d
Cleared Dec 05, 1994
BIOPSY DEVICE ACCESSORY
K944252 · FCK
Biopsys Medical, Inc.
Gastroenterology & Urology · 97d
Cleared Dec 05, 1994
KIS-II IMPLANT SYSTEM/DRILLS
K944356 · DZE
Implant Center of the Palm Beaches
Dental · 111d
Cleared Dec 05, 1994
MODEL PBD ESU PENCIL
K944363 · GEI
Coral Medical, Inc.
General & Plastic Surgery · 89d
Cleared Dec 05, 1994
PISTON SYRINGE
K944941 · CBT
Martell Medical Products, Inc.
Anesthesiology · 59d
Cleared Dec 05, 1994
COLLEGIATE COLORS
K945006 · HQY
Trey Optics
Ophthalmic · 53d
Cleared Dec 05, 1994
ROSEBUD DISSECTOR
K945332 · GDY
Lorrex Health Products
General & Plastic Surgery · 34d
Cleared Dec 05, 1994
CHERRY PIT DISSECTOR
K945334 · GDY
Lorrex Health Products
General & Plastic Surgery · 34d
Cleared Dec 05, 1994
PEANUT DISSECTOR
K945336 · GDY
Lorrex Health Products
General & Plastic Surgery · 34d
Cleared Dec 05, 1994
SCANLAN(R) THORACOSCOPIC SCISSORS, CLAMP, FORCEPS, NEEDLE HOLDER
K945474 · GCJ
Scanlan Intl., Inc.
General & Plastic Surgery · 27d
Cleared Dec 02, 1994
KTP/532, KTP/YAG AND KTP/YAG XP
K931445 · GEX
Laser Surgical Systems
General & Plastic Surgery · 620d
Cleared Dec 02, 1994
BIOSITE DIAGNOSTICS - TRIAGE PANEL FOR DRUGS OF ABUSE PLUS TRICYCLIC...
K934340 · LFI
Biosite Incorporated
Toxicology · 450d
Cleared Dec 02, 1994
APTT-ES
K935169 · GFO
Helena Laboratories
Hematology · 402d
Cleared Dec 02, 1994
R2 PADS, R2 CATH PADS, R2 PACE PADS, R2 DISPERSIVE PAD
K935371 · DRX
R2 Medical Systems
Cardiovascular · 389d
Cleared Dec 02, 1994
STERI-VAC GAS STERILIZER MODEL 8XL
K941748 · FLF
3M Health Care, Ltd.
General Hospital · 238d
Cleared Dec 02, 1994
PRO-TEC DISPOSABLE SHARPS CONTAINERS
K942179 · FMI
Pro-Tec Containers, Inc.
General Hospital · 212d
Cleared Dec 02, 1994
COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR
K942847 · LAR
Roche Diagnostic Systems, Inc.
Toxicology · 169d