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
98593–98616 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 12, 1996
MATAR GENERAL PURPOSE DISINFECTANT
K960583 · LRJ
Huntington Laboratories, Inc.
General Hospital · 29d
Cleared Mar 12, 1996
FABRIS LAN SUNGLASSES
K960786 · HQY
Fabris Lane Intl., Ltd.
Ophthalmic · 15d
Cleared Mar 12, 1996
D & K SUNGLASSES
K960797 · HQY
D&K Stores, Inc.
Ophthalmic · 14d
Cleared Mar 11, 1996
BALLOON ELECTROSURGICAL PROBES AND DEVICES
K943014 · GEI
Ximed Medical Systems
General & Plastic Surgery · 626d
Cleared Mar 11, 1996
PORCINE FACTOR VIII
K952321 · GGN
Helena Laboratories
Hematology · 298d
Cleared Mar 11, 1996
SONOS IMAGING SYSTEM (2000/2500 & 1000/1500)
K952540 · IYO
Hewlett-Packard Co.
Radiology · 293d
Cleared Mar 11, 1996
SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS
K953598 · GKZ
Serono Diagnostics, Inc.
Hematology · 223d
Cleared Mar 11, 1996
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
K953750 · DRF
Boston Scientific Corp
Cardiovascular · 214d
Cleared Mar 11, 1996
WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE
K953854 · FKP
Integrated Biomedical Technology, Inc.
Gastroenterology & Urology · 217d
Cleared Mar 11, 1996
RIGHT ANGLE LASER FIBERS
K954597 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 160d
Cleared Mar 11, 1996
PROTHROMBIN TIME TEST CARD
K954625 · GJS
Cardiovascular Diagnostics, Inc.
Hematology · 166d
Cleared Mar 11, 1996
ROGOZINSKI THORACOLUMBAR SPINAL ROD
K954696 · KWP
Smith & Nephew Richards, Inc.
Orthopedic · 151d
Cleared Mar 11, 1996
URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION)
K954977 · JRE
Teco Diagnostics
Chemistry · 147d
Cleared Mar 11, 1996
LMI OCCLUSION CATHETER
K955125 · DXE
Lucas Medical, Inc.
Cardiovascular · 123d
Cleared Mar 11, 1996
OES LAPARO-THORACO VIDEOSCOPE TYPE V
K955403 · HET
Olympus America, Inc.
Obstetrics & Gynecology · 105d
Cleared Mar 11, 1996
DIASTAT VASCULAR ACCESS GRAFT
K955532 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 97d
Cleared Mar 11, 1996
ESSENCE GUIDEWIRE
K955637 · DQX
Cordis Neurovascular, Inc.
Cardiovascular · 91d
Cleared Mar 11, 1996
KC 4A MICRO COAGULATION ANALYZER SET/SYSTEM
K955735 · JPA
Sigma Diagnostics, Inc.
Hematology · 84d
Cleared Mar 11, 1996
ACS PHENYTOIN ASSAY
K955873 · LGR
Ciba Corning Diagnostics Corp.
Toxicology · 76d
Cleared Mar 11, 1996
MEGA PTA BALLOON CATHETER
K955886 · LIT
Cordis Corp.
Cardiovascular · 74d
Cleared Mar 11, 1996
BARBITURATE EIA ESSAY (MODIFICATION)
K955928 · DIS
Diagnostic Reagents, Inc.
Toxicology · 84d
Cleared Mar 11, 1996
EXAFLEX IMPRESSION MATERIAL (MODIFICATION)
K955932 · ELW
GC America, Inc.
Dental · 89d
Cleared Mar 11, 1996
ISE CALIBRANT A & B, ISE LIQUID REAGENT FOR PARAMAX CLINAK SYSTEMS
K960085 · JIX
Alko Diagnostic Corp.
Chemistry · 60d
Cleared Mar 11, 1996
PENROSE DRAIN MODELS 6001 - 6007
K960099 · GCY
Sil-Med Corp.
General & Plastic Surgery · 60d