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
84289–84312 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 13, 1999
PASCO MIC AND MIC/ID PANELS, CEFTRIAXONE
K992562 · JTN
Pasco Laboratories, Inc.
Microbiology · 72d
Cleared Oct 13, 1999
VIDEO PLUS SYSTEM, SERIES 95000
K992666 · LLZ
Camtronics, Ltd.
Radiology · 65d
Cleared Oct 13, 1999
NITRA-TOUCH STERILE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE
K992768 · LZA
Ansell Perry
General Hospital · 57d
Cleared Oct 13, 1999
SENSICARE XP VINYL POWDER FREE MEDICAL EXAMINATION GLOVE
K992865 · LYZ
Maxxim Medical
General Hospital · 49d
Cleared Oct 12, 1999
ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800
K992056 · KRH
Sulzer Carbomedics, Inc.
Cardiovascular · 116d
Cleared Oct 12, 1999
SNT IMAGE ANALYSIS SYSTEM
K992354 · LLZ
Surgical Navigation Technologies, Inc.
Radiology · 90d
Cleared Oct 12, 1999
TG MEDICAL POWDERED NITRILE EXAMINATION GLOVES
K992360 · LZA
Tg Medical Sdn. Bhd.
General Hospital · 89d
Cleared Oct 12, 1999
PASCO MIC AND MIC/ID PANELS, MEROPENEM
K992546 · JTN
Pasco Laboratories, Inc.
Microbiology · 74d
Cleared Oct 12, 1999
VISTA BRITE TIP CATHETERS
K992673 · DQY
Cordis Corp.
Cardiovascular · 63d
Cleared Oct 08, 1999
ETCO2 VITAL SIGNS MODULE
K983864 · CCK
Mennen Medical, Inc.
Anesthesiology · 340d
Cleared Oct 08, 1999
VIRGO MRI SYSTEM
K990153 · LNH
Millennium Technology Services
Radiology · 262d
Cleared Oct 08, 1999
VIEWPOINT ENT/ORTHOPEDIC OPTION
K991256 · HAW
Philips Medical Systems (Cleveland),...
Neurology · 178d
Cleared Oct 08, 1999
CIDEX OPA SOLUTION
K991487 · MED
Advanced Sterilization Products
General Hospital · 163d
Cleared Oct 08, 1999
PERMOBIL POWERED WHEELCHAIR 1280
K991658 · ITI
Permobil AB
Physical Medicine · 147d
Cleared Oct 08, 1999
BROWNE CIDEX OPA INDICATOR
K991709 · JOJ
Albert Browne , Ltd.
General Hospital · 142d
Cleared Oct 08, 1999
QUANTEC-E IRRIGATION SYSTEM 2
K992195 · EIA
Sybron Dental Specialties, Inc.
Dental · 101d
Cleared Oct 08, 1999
MASIMO SET RADICAL PULSE OXIMETER, LNOP-ADT, LNOP-PDT, LNOP-NEO, LNOP-NEO PT,...
K992238 · DQA
Masimo Corp.
Anesthesiology · 98d
Cleared Oct 08, 1999
RX MEGALINK SDS BILIARY STENT SYSTEM, OTW MEGALINK SDS BILIARY STENT SYSTEM
K992319 · FGE
Guidant Corp.
Gastroenterology & Urology · 88d
Cleared Oct 08, 1999
3M CLINPRO SEALANT
K992326 · EBC
3M Company
Dental · 87d
Cleared Oct 08, 1999
EBI OMEGA 21 SYSTEM
K992333 · MNI
Electro-Biology, Inc.
Orthopedic · 87d
Cleared Oct 08, 1999
ENDOSSEOUS IMPLANTS AND ABUTMENTS- TIN COATING
K992334 · DZE
Implant Innovations, Inc.
Dental · 87d
Cleared Oct 08, 1999
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP...
K992340 · DQA
Masimo Corp.
Anesthesiology · 87d
Cleared Oct 08, 1999
CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS
K992347 · DQO
Cordis Corp.
Cardiovascular · 86d
Cleared Oct 08, 1999
SEALOUETTE FIBRIN SEALANT APPLICATOR
K992351 · FMF
Biosurgical Corp.
General Hospital · 86d