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
86761–86784 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 19, 1999
AROMAPATCH
K984345 · LRD
Envis, Inc.
Ear, Nose, Throat · 105d
Cleared Mar 19, 1999
NATURAL RUBBER PRE-POWDERED COLORED & FLAVORED PATIENT EXAMINATION GLOVES...
K984449 · LYY
P.T. Irama Dinamika Latex
General Hospital · 95d
Cleared Mar 19, 1999
DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS
K984547 · EWO
Resound Corp.
Ear, Nose, Throat · 87d
Cleared Mar 19, 1999
SILON DUAL-DRESS
K990042 · FRO
Bio Med Sciences, Inc.
General & Plastic Surgery · 72d
Cleared Mar 19, 1999
PAIN CONTROL INFUSION PUMP
K990101 · FRN
Sgarlato Laboratories, Inc.
General Hospital · 66d
Cleared Mar 19, 1999
MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, TSX-101A (AQUILION,MULTI)
K990134 · JAK
Toshiba America Medical Systems, In.C
Radiology · 64d
Cleared Mar 19, 1999
AUTOMARQER
K990184 · POV
Hamilton Thorne Research
Hematology · 58d
Cleared Mar 19, 1999
EXCITE
K990534 · KLE
Ivoclar North America, Inc.
Dental · 28d
Cleared Mar 19, 1999
SIEMENS SC 8000 BEDSIDE MONITOR WITH ADVANCED COMMUNICATION OPTION
K990563 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 25d
Cleared Mar 19, 1999
SYMBIOCERAM
K990629 · EIH
Ney Dental, Inc.
Dental · 21d
Cleared Mar 19, 1999
PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE
K990646 · EKX
Nsk Nakanishi, Inc.
Dental · 18d
Cleared Mar 19, 1999
SAS HCG SERUM CONTROLS
K990720 · JJX
Sa Scientific, Inc.
Chemistry · 14d
Cleared Mar 19, 1999
SAS HCG URINE CONTROLS
K990755 · JJX
Sa Scientific, Inc.
Chemistry · 11d
Cleared Mar 18, 1999
PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1
K983336 · LKT
Diagnostic Products Corp.
Microbiology · 176d
Cleared Mar 18, 1999
GILTECH PLUS CONNECTING TUBE SET
K983624 · KDH
Giltech Plus, Inc.
Gastroenterology & Urology · 154d