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
88105–88128 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 23, 1998
TREX TILT C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING...
K982427 · OWB
Trex Medical Corp.
Radiology · 72d
Cleared Sep 23, 1998
EWC: ECG CABLE AND LEADWIRE SYSTEMS
K982817 · DSA
Ewc
Cardiovascular · 43d
Cleared Sep 23, 1998
MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENT
K982960 · KNW
Medical Device Technologies, Inc.
Gastroenterology & Urology · 30d
Cleared Sep 23, 1998
XENON LIGHT SOURCE, MODELS LS6180, LS6035
K982962 · GCT
Contec Medical Vision, Ltd.
Gastroenterology & Urology · 30d
Cleared Sep 23, 1998
NBIL
K983134 · MQM
Abbott Laboratories
Chemistry · 15d
Cleared Sep 22, 1998
JM-102 JAUNDICE METER
K972309 · MQM
Air-Shields, Inc.
Chemistry · 459d
Cleared Sep 22, 1998
BIONECT HYDROGEL GAUZE PADS
K973721 · MGQ
Fidia Pharmaceutical Corp.
General & Plastic Surgery · 357d
Cleared Sep 22, 1998
BIONECT HYDROGEL FOAM
K973722 · MGQ
Fidia Pharmaceutical Corp.
General & Plastic Surgery · 357d
Cleared Sep 22, 1998
BIONECT HYDROGEL SPRAY
K973724 · MGQ
Fidia Pharmaceutical Corp.
General & Plastic Surgery · 357d
Cleared Sep 22, 1998
BIONECT CLEAR HYDROGEL
K973725 · MGQ
Fidia Pharmaceutical Corp.
General & Plastic Surgery · 357d
Cleared Sep 22, 1998
IMMUNODOT MONO-G TEST
K974226 · LSE
Genbio
Microbiology · 314d
Cleared Sep 22, 1998
IMMUNODOT MONO-M TEST
K974244 · LSE
Genbio
Microbiology · 314d
Cleared Sep 22, 1998
OSTEONICS POLYETHYLENE ACETABULAR COMPONENTS
K974685 · JDI
Osteonics Corp.
Orthopedic · 280d
Cleared Sep 22, 1998
KAPLAN PENDULASER 115 SURGICAL LASER WITH OPTOSCAN II
K980398 · GEX
Optomedic Medical Technologies , Ltd.
General & Plastic Surgery · 232d
Cleared Sep 22, 1998
BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST
K980798 · LYR
Princeton BioMeditech Corp.
Microbiology · 204d
Cleared Sep 22, 1998
FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA
K980930 · LFL
Fibra Sonics, Inc.
General & Plastic Surgery · 194d
Cleared Sep 22, 1998
KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH...
K981260 · HDB
Clinical Innovations, Inc.
Obstetrics & Gynecology · 169d
Cleared Sep 22, 1998
VTEC-RPLA SEIKEN
K981734 · GNA
Denka Seiken'S
Microbiology · 127d
Cleared Sep 22, 1998
ALM PRISMALIX (PRX) SURGICAL LIGHT
K982063 · FSY
Alm Surgical Equipment, Inc.
General & Plastic Surgery · 102d
Cleared Sep 22, 1998
ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM
K982073 · GCJ
Anchor Products Co.
General & Plastic Surgery · 102d
Cleared Sep 22, 1998
PREMIER AP
K982221 · GZJ
American Imex
Neurology · 90d
Cleared Sep 22, 1998
CHROMA ZONE COLOR STAIN
K982259 · EBF
Kuraray America, Inc.
Dental · 88d
Cleared Sep 22, 1998
WAKO DIRECT LDL-C
K982271 · MRR
Wako Chemicals USA, Inc.
Chemistry · 85d
Cleared Sep 22, 1998
SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENT
K982305 · DZE
Sulzer Calcitek, Inc.
Dental · 83d