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
86233–86256 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 23, 1999
SOUTHLAND POWDERFREE (POLYMER-COATED) LATEX EXAMINATION GLOVES
K990751 · LYY
Southland Products Co., Ltd.
General Hospital · 15d
Cleared Mar 23, 1999
DIRECTFLOW ARTERIAL CANNULA
K990772 · DWF
Heartport, Inc.
Cardiovascular · 14d
Cleared Mar 22, 1999
ATLANTIS ABUTMENT AND ATLANTIS ABUTMENT SCREW
K981858 · DZE
Atlantis Components, Inc.
Dental · 299d
Cleared Mar 22, 1999
NEUROTUBE
K983007 · JXI
Neuroregen, LLC
Neurology · 206d
Cleared Mar 22, 1999
ALOKA SSD-900 DIAGNOSTIC ULTRASOUND SYSTEM
K983879 · IYO
Aloka Co., Ltd.
Radiology · 140d
Cleared Mar 22, 1999
AIR TECHNIQUES' DENTO-VAC
K984584 · EIA
Air Techniques, Inc.
Dental · 88d
Cleared Mar 22, 1999
DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTURE
K990090 · GAR
Aesculap, Inc.
General & Plastic Surgery · 70d
Cleared Mar 22, 1999
ISOBAR SPINAL SYSTEM
K990118 · MNH
Scien'Tx USA, Inc.
Orthopedic · 68d
Cleared Mar 22, 1999
OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR,...
K990249 · CEP
Phamatech
Chemistry · 55d
Cleared Mar 22, 1999
ETEST MINOCYCLINE
K990297 · JWY
Ab Biodisk
Microbiology · 52d
Cleared Mar 22, 1999
KSEA ENDOSCOPE HOLDER
K990334 · OCV
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 47d
Cleared Mar 22, 1999
MOSS GASTROSTOMY TUBE
K990389 · KNT
Moss Tubes, Inc.
Gastroenterology & Urology · 42d
Cleared Mar 22, 1999
ARCHITECT PROGESTERONE MASTERCHECK MODEL #6C26-05
K990393 · JJX
Bio-Rad
Chemistry · 41d
Cleared Mar 22, 1999
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.)
K990460 · JIX
Roche Diagnostics Corp.
Chemistry · 38d
Cleared Mar 22, 1999
IGM FLEX REAGENT CARTRIDGE
K990553 · CFQ
Dade Behring, Inc.
Immunology · 28d
Cleared Mar 22, 1999
DIMENSION SPECIAL PROTEIN CALIBRATOR
K990554 · JIT
Dade Behring, Inc.
Immunology · 28d
Cleared Mar 22, 1999
TISPORT X AND TISPORT XC
K990555 · IOR
Tisport
Physical Medicine · 28d
Cleared Mar 22, 1999
THE STELLAR TILT, MANUALLY OPERATED WHEELCHAIR
K990557 · IOR
Pdg Product Design Group, Inc.
Physical Medicine · 28d
Cleared Mar 22, 1999
MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERS
K990707 · DQY
Medtronics Interventional Vascular
Cardiovascular · 18d
Cleared Mar 22, 1999
NUVOLASE 532 LASER SYSTEM
K990725 · GEX
American Laser Corp.
General & Plastic Surgery · 17d
Cleared Mar 22, 1999
NUVOLASE 532 CUTANEOUS LASER SYSTEM
K990780 · GEX
American Laser Medical
General & Plastic Surgery · 13d
Cleared Mar 19, 1999
VASO PRESS SYSTEM
K974393 · JOW
Britt Corp., Inc.
Cardiovascular · 483d
Cleared Mar 19, 1999
MACROPORE PROTECTIVE SHEET
K983360 · JEY
Pacific Materials and Interfaces
Dental · 176d
Cleared Mar 19, 1999
SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500
K983572 · MNR
Healthdyne Technologies, Inc.
Anesthesiology · 157d