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
97081–97104 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 18, 1996
PEGASUS DENTAL ALLOY
K962302 · EJT
Sterngold/Implamed
Dental · 31d
Cleared Jul 18, 1996
STERNGOLD CF
K962303 · EJT
Sterngold/Implamed
Dental · 31d
Cleared Jul 18, 1996
PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT
K962348 · KLE
Dentsply Intl.
Dental · 30d
Cleared Jul 18, 1996
XENON LIGHTSOURCE
K962365 · GCT
Dsp Worldwide
Gastroenterology & Urology · 29d
Cleared Jul 18, 1996
PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT...
K962604 · FAQ
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 16d
Cleared Jul 17, 1996
KSEA SCALP BLOOD COLLECTION SET
K954982 · HGK
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 260d
Cleared Jul 17, 1996
HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KIT
K960029 · CEF
Morax
Chemistry · 197d
Cleared Jul 17, 1996
PULSE*SPRAY INFUSION SYSTEM
K961763 · QEY
Angiodynamics, Div. E-Z-Em, Inc.
Cardiovascular · 71d
Cleared Jul 17, 1996
EUB-905
K962308 · IYO
Hitachi Medical Corp. of America
Radiology · 30d
Cleared Jul 16, 1996
IMX RUBELLA IGG
K951541 · LFX
Abbott Laboratories
Microbiology · 470d
Cleared Jul 16, 1996
EIDOS 5003 HOLTER SYSTEM
K952969 · DQK
New Product Development, Inc.
Cardiovascular · 385d
Cleared Jul 16, 1996
COLLARLESS POLISHED TAPER HIP PROSTHESIS
K960658 · JDI
Zimmer, Inc.
Orthopedic · 151d
Cleared Jul 16, 1996
QUIK-FIL VAPORIZER KEYED FILLER
K961468 · CAD
Penlon , Ltd.
Anesthesiology · 90d
Cleared Jul 16, 1996
SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984)
K961476 · CAF
Salter Labs
Anesthesiology · 89d
Cleared Jul 16, 1996
ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER
K961649 · HWC
Smith & Nephew Endoscopy, Inc.
Orthopedic · 77d
Cleared Jul 16, 1996
NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID STIMULATING HORMONE THIRD...
K961650 · JLW
Nichols Institute Diagnostics
Chemistry · 77d
Cleared Jul 16, 1996
MOUSE ANTI-HUMAN CD3, T-CELL, FITC AND CD4, T-CELL, (HELPER/INDUCER) RPE
K961701 · GKZ
Dako Corp.
Hematology · 75d
Cleared Jul 16, 1996
PROFORE FOUR-LAYER BANDAGE SYSTEM KIT
K961775 · EFQ
Smith & Nephew United, Inc.
General & Plastic Surgery · 69d
Cleared Jul 16, 1996
VALPROIC ACID EIA TEST
K961988 · LEG
Diagnostic Reagents, Inc.
Toxicology · 56d
Cleared Jul 16, 1996
USSC BRAIDED SYNTHETIC ABSORBABLE SUTURE
K961997 · GAM
United States Surgical, A Division of...
General & Plastic Surgery · 55d
Cleared Jul 16, 1996
N CRP STANDARD SY
K962406 · JIX
Behring Diagnostics, Inc.
Chemistry · 25d
Cleared Jul 16, 1996
N PROTEIN STANDARD PY
K962410 · JIX
Behring Diagnostics, Inc.
Hematology · 25d
Cleared Jul 15, 1996
TRUSTEX FLAVOR CONDON IN COLORS
K946103 · HIS
Line One Laboratories & Trading Co.
Obstetrics & Gynecology · 579d
Cleared Jul 15, 1996
PATHFINDER 700 HOLTER ANALYZER
K951902 · DQK
Reynolds Medical , Ltd.
Cardiovascular · 448d