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
112561–112584 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 27, 1993
FLOSS PLUS
K931353 · JES
Floss Plus, Inc.
Dental · 132d
Cleared Jul 27, 1993
SITERITE NEEDLE GUIDE (MODIFIED)
K931403 · DQY
Dymax Corp
Cardiovascular · 130d
Cleared Jul 27, 1993
CHEMILUMINESCENCE DHEA-S IMMUNOASSAY
K931601 · JKC
Nichols Institute
Chemistry · 117d
Cleared Jul 27, 1993
NUCLEAR ASSOCIATES MODEL 34-070 BRACHYTHERAPY CAL.
K931657 · KPT
Victoreen, Inc.
Radiology · 113d
Cleared Jul 27, 1993
TOTAL BILIRUBIN
K931888 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 103d
Cleared Jul 27, 1993
CREATINE KINASE TEST
K931889 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 103d
Cleared Jul 27, 1993
LCR GENERATOR
K931998 · IZO
Philips Medical Systems (Cleveland),...
Radiology · 95d
Cleared Jul 27, 1993
DU PONT ISE SENSOR CARTRIDGE/REVISED TCO2 ELECTROD
K932044 · CEM
Dupont Medical Products
Chemistry · 91d
Cleared Jul 27, 1993
LIGHTED INTUBATION SYLET
K932081 · BSR
Aaron Medical, Inc.
Anesthesiology · 89d
Cleared Jul 27, 1993
RADIOACTIVE SAMARIUM 145 SEEDS/SOURCES #2341-2345
K932242 · KXK
Best Industries
Radiology · 81d
Cleared Jul 27, 1993
PHONAK PICO-FORTE SC-2
K932734 · ESD
Phonak, Inc.
Ear, Nose, Throat · 50d
Cleared Jul 27, 1993
PHONAK PICO-FORTE SC-D-2
K932735 · ESD
Phonak, Inc.
Ear, Nose, Throat · 50d
Cleared Jul 27, 1993
STARKEY TRILOGY II PROGRAMMABLE HEARING AID
K933113 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 32d
Cleared Jul 26, 1993
SPECTURN, MODEL TTK-128
K923180 · IYX
Harpell Assoc., Inc.
Radiology · 391d
Cleared Jul 26, 1993
OGDEN ANCHOR
K924367 · JDR
Advanced Surgical Implants, Inc.
Orthopedic · 332d
Cleared Jul 26, 1993
UNI I
K925759 · ERA
Rudolf Riester GmbH & Co. KG
Ear, Nose, Throat · 255d
Cleared Jul 26, 1993
MODEL #QSC-200-21 20 CM. QUADRATURE SHOULDER COIL
K930045 · LNH
Mri Devices Corp.
Radiology · 202d
Cleared Jul 26, 1993
VITALOGRAPH DATA STORAGE SPIROMETER
K930085 · BTY
Vitalograph , Ltd.
Anesthesiology · 200d
Cleared Jul 26, 1993
MODEL 600GE-64: BILATERAL BREAST COIL
K930122 · LNH
Medical Advances, Inc.
Radiology · 195d
Cleared Jul 26, 1993
MAMMORX
K930246 · IYE
Diacor, Inc.
Radiology · 188d
Cleared Jul 26, 1993
ACE UNIVERSAL RECONSTRUCTION PLATE
K930592 · HRS
Ace Medical Co.
Orthopedic · 172d
Cleared Jul 26, 1993
ACUTRACT
K930834 · HWC
Acu Med, Inc.
Orthopedic · 159d
Cleared Jul 26, 1993
WELCH ALLYN EARCLEANER
K931946 · KYZ
Welch Allyn, Inc.
General Hospital · 98d
Cleared Jul 26, 1993
RINN UNIVERSAL COLLIMATOR
K932134 · IZX
Rinn Corp.
Radiology · 84d