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
118393–118416 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 16, 1992
CODMAN SOF'WIRE (TM) KIT
K915581 · JDQ
Codman & Shurtleff, Inc.
Orthopedic · 34d
Cleared Jan 16, 1992
CANNULATED DRILL BIT
K915692 · HTW
W.L. Gore & Associates, Inc.
Orthopedic · 24d
Cleared Jan 15, 1992
MODIFIED SEISMOCARDIOGRAPH
K910994 · DSB
Seismed Instruments, Inc.
Cardiovascular · 318d
Cleared Jan 15, 1992
DPI-1106 IMPLANT, MODIFICATION
K911776 · DZE
Minimatic Implant Technology
Dental · 289d
Cleared Jan 15, 1992
AD-TECH EPIDURAL PEG ELECTRODE
K912760 · GYC
Ad-Tech Medical Instrument Corp
Neurology · 205d
Cleared Jan 15, 1992
PARI-MASTER
K912805 · CAF
Paul Ritzau Pari GmbH
Anesthesiology · 205d
Cleared Jan 15, 1992
COLLINS DIGITAL PULMONARY MANOMETER
K912946 · BXR
Warren E. Collins, Inc.
Anesthesiology · 194d
Cleared Jan 15, 1992
NON REBREATHING MASK
K913164 · KGB
Specialty Packaging Producs, Inc.
Anesthesiology · 182d
Cleared Jan 15, 1992
TRACH T ADAPTER
K913216 · BZA
Specialty Packaging Producs, Inc.
Anesthesiology · 180d
Cleared Jan 15, 1992
IVEX-TPN EXTENSION FILTER SET
K913308 · FPB
Abbott Laboratories
General Hospital · 174d
Cleared Jan 15, 1992
DOBBHOFF(R) SINGLE PASS PEG KIT
K913784 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 145d
Cleared Jan 15, 1992
HY-PREP SYSTEM
K913809 · JQW
Hyperion, Inc.
Chemistry · 142d
Cleared Jan 15, 1992
TIA CRP TEST KIT
K914155 · DCK
Crestat Diagnostics, Inc.
Immunology · 121d
Cleared Jan 15, 1992
DSL ULTRA-SENSITIVE CALCITONIN RIA (DSL 5200)
K914429 · JKR
Diagnostic Systems Laboratories, Inc.
Chemistry · 103d
Cleared Jan 15, 1992
MULTIPLE STERILE SURGICAL DRAPE PACK
K914605 · KKX
Assured Surgical Products, Inc.
General Hospital · 90d
Cleared Jan 15, 1992
INDIVIDUAL/LARGE/BELT FIRST AID KITS
K914691 · LYY
The Lighthouse For the Blind, Inc.
General Hospital · 89d
Cleared Jan 15, 1992
ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO TEST KIT
K914756 · JLW
Medix Biotech, Inc.
Chemistry · 85d
Cleared Jan 15, 1992
PN 62290 0.22 MICRON MICRO INFUS I.V. EXTEN SET
K914792 · FPA
Filtertek, Inc.
General Hospital · 84d
Cleared Jan 15, 1992
DADE(R) ALPHA 2 ANTIPLASMIN(2 2-AP) CHROMO ASSAY
K914818 · GGP
Baxter Diagnostics, Inc.
Hematology · 82d
Cleared Jan 15, 1992
ANTINUCLEAR ANTIBODY (ANA) SCREENING TEST KIT
K914853 · LJM
Reads Medical Products, Inc.
Immunology · 79d
Cleared Jan 15, 1992
CEDIA(R) CARBAMAZEPINE ASSAY
K914857 · KLT
Microgenics Corp.
Toxicology · 78d
Cleared Jan 15, 1992
MARLOW LAPAROSCOPIC SCISSORS
K914869 · GCJ
Marlo Surgical Technology
General & Plastic Surgery · 78d
Cleared Jan 15, 1992
NOVA 4 NA/K/C1/TCO2/LI ANALYZER
K915176 · JGS
Nova Biomedical Corp.
Chemistry · 61d
Cleared Jan 15, 1992
ENDOPATH DISPOSABLE TROCAR SLEEVE W/DILATING OBTUR
K915239 · GCJ
Ethicon, Inc.
General & Plastic Surgery · 55d