FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
99769–99792 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 16, 1996
GAMMA SYSTEM
K955473 · JDI
Zimmer, Inc.
Orthopedic · 78d
Cleared Feb 16, 1996
SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM
K955644 · KLT
Beckman Instruments, Inc.
Immunology · 66d
Cleared Feb 16, 1996
VANCOMYCIN FPIA REAGENT SET
K955716 · LEH
Sigma Diagnostics, Inc.
Toxicology · 63d
Cleared Feb 16, 1996
INDIGO MEDICAL MODEL IDL 830E
K955758 · GEX
Indigo Medical, Inc.
General & Plastic Surgery · 59d
Cleared Feb 16, 1996
TEX-AID BLUE
K955856 · LKY
Laborie Medical Technologies, Ltd.
Gastroenterology & Urology · 52d
Cleared Feb 16, 1996
A549 CELL CULTURE
K955921 · KIR
Viratest Intl., Inc.
Microbiology · 64d
Cleared Feb 16, 1996
TRIAGE PANEL FOR DRUGS OF ABUSE MODEL 9500/93000
K955934 · DKZ
Biosite Incorporated
Toxicology · 65d
Cleared Feb 16, 1996
IMMULITE ACTH
K960066 · CKG
Diagnostic Products Corp.
Chemistry · 42d
Cleared Feb 16, 1996
JAMES KOREA OPTICAL FRAMES & SUNGLASSES
K960289 · HQY
James Korea Co., Ltd.
Ophthalmic · 25d
Cleared Feb 16, 1996
BUDDY WHEELCHAIR
K960402 · IOR
Metro-Care
Physical Medicine · 18d
Cleared Feb 15, 1996
TOTAL CO2
K951221 · KHS
Randox Laboratories, Ltd.
Chemistry · 332d
Cleared Feb 15, 1996
EBNA ENZYME IMMUNOASSAY KIT
K951822 · LLM
Granbio, Inc.
Microbiology · 301d
Cleared Feb 15, 1996
BIOLOGIC-DT SYSTEM
K953751 · FLD
Hemocleanse, Inc.
Gastroenterology & Urology · 189d
Cleared Feb 15, 1996
ACL-5500 PRECISION CURING UNIT (PCU)
K953898 · EBZ
Ion Laser Technology
Dental · 181d
Cleared Feb 15, 1996
MOSS MIAMI SPINAL SYSTEM (ANTERIOR USE)
K953915 · MNH
Depuy, Inc.
Orthopedic · 178d
Cleared Feb 15, 1996
ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW
K954246 · HWC
Acufex Microsurgical, Inc.
Orthopedic · 157d
Cleared Feb 15, 1996
ACCU-CHEK ADVANTAGE TEST STRIPS
K954833 · LFR
Boehringer Mannheim Corp.
Chemistry · 118d
Cleared Feb 15, 1996
INTERMOORE FRACTURE HIP STEM
K954854 · LWJ
Intermedics Orthopedics
Orthopedic · 115d
Cleared Feb 15, 1996
HOWMEDICA BIOABSORBABLE PIN
K955806 · HTY
Howmedica, Inc.
Orthopedic · 55d
Cleared Feb 15, 1996
TRIAGE PANEL FOR DRUGS OF ABUSE/TRICYCLIC ANTIDEPRESSANTS
K955935 · DKZ
Biosite Incorporated
Toxicology · 64d
Cleared Feb 14, 1996
SPINE FIXATION
K943827 · MNH
Danek Medical, Inc.
Orthopedic · 558d
Cleared Feb 14, 1996
FINN KNEE SYSTEM
K945028 · KRO
Biomet, Inc.
Orthopedic · 489d
Cleared Feb 14, 1996
KEISEI
K950613 · CAE
Keisei (Usa) Co., Ltd.
Anesthesiology · 369d
Cleared Feb 14, 1996
AUGMENT-T POSTERIOR SPINAL SYSTEM
K950717 · MNH
Sofamor Danek USA,Inc.
Orthopedic · 363d