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
73369–73392 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 27, 2002
GALAXY SERIES WHEELCHAIR
K023993 · IOR
Evermed Corp.
Physical Medicine · 24d
Cleared Dec 26, 2002
MASTEL 1 FOLDER IMPLANTATION SYSTEM
K022723 · KYB
Mastel Precision, Inc.
Ophthalmic · 132d
Cleared Dec 26, 2002
ISOCARE ONE STEP SPERM PROCESSING MEDIUM CAT# 2207-12
K023222 · MQL
Invitrocare, Inc.
Obstetrics & Gynecology · 90d
Cleared Dec 26, 2002
INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200
K023259 · FDF
Helix Medical, Inc.
Gastroenterology & Urology · 87d
Cleared Dec 26, 2002
KEGELMASTER 2000
K023305 · HIR
Kegelmaster 2000 , Ltd.
Gastroenterology & Urology · 84d
Cleared Dec 26, 2002
MODIFICATION TO ALKP
K023807 · CJE
Abbott Laboratories
Chemistry · 42d
Cleared Dec 24, 2002
HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 5065, 5075, 5087, 5089
K021509 · JOW
Hygia Health Services, Inc.
Cardiovascular · 229d
Cleared Dec 24, 2002
USI-2000 ULTRASOUND SYSTEM WITH AUTOMATED SCANNING ACCESSORY
K022517 · IYN
U-Systems, Inc.
Radiology · 147d
Cleared Dec 24, 2002
TELEGRAPH HUMERAL NAIL
K023241 · HSB
Fournitures Hospitalieres Industrie
Orthopedic · 85d
Cleared Dec 24, 2002
CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR...
K023349 · LPL
Contamac, Ltd.
Ophthalmic · 78d
Cleared Dec 24, 2002
CHEETAH I.V.D.S., MODEL 2002P
K023370 · DQK
Cheetah Medical, Inc.
Cardiovascular · 77d
Cleared Dec 24, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-GENTAMICIN GN (0.25-16UG/ML)
K023634 · LON
Becton, Dickinson & CO
Microbiology · 56d
Cleared Dec 24, 2002
RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE
K023667 · KRO
Plus Orthopedics
Orthopedic · 54d
Cleared Dec 24, 2002
QUICKCHECK LIQUID CHEMISTRY CONTROL (ASSAYED AND UNASSAYED), LEVELS 1, 2, AND 3
K023731 · JJY
Consolidated Technology
Chemistry · 48d
Cleared Dec 24, 2002
RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS...
K023784 · LBR
Hemagen Diagnostics, Inc.
Chemistry · 42d
Cleared Dec 24, 2002
AMMONIA ASSAY FOR THE ADVIA 1650
K023841 · JIF
Bayer Diagnostics Corp.
Immunology · 36d
Cleared Dec 24, 2002
SCOUT BOSS
K023961 · ITI
Burke, Inc.
Physical Medicine · 25d
Cleared Dec 24, 2002
NEW STAR LASERS, INC. DOVE ND: YAG LASER SYSTEM, MODEL: NS-160
K023962 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 25d
Cleared Dec 24, 2002
FEMOSTOP FEMORAL COMPRESSION SYSTEM
K024107 · DXC
Radi Medical Systems AB
Cardiovascular · 11d
Cleared Dec 23, 2002
LTFS230
K021775 · LNS
Healthtronics, Inc.
Gastroenterology & Urology · 208d
Cleared Dec 23, 2002
AIM-V (R) MEDIUM, MODEL 087-0112
K022086 · NDS
Invitrogen Corporation
Gastroenterology & Urology · 179d
Cleared Dec 23, 2002
DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE
K022500 · KPO
Rockwell Medical Technologies, Inc.
Gastroenterology & Urology · 147d
Cleared Dec 23, 2002
PAROS CRP
K022690 · DCN
Horiba, Ltd.
Immunology · 132d
Cleared Dec 23, 2002
AIA-PACK CA 19-9
K023239 · NIG
Tosoh Corp.
Immunology · 87d