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
101185–101208 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 30, 1995
MANAN NEPHROSTOMY DRAINAGE CATHETER
K953547 · LJE
Manan Medical Products, Inc.
Gastroenterology & Urology · 33d
Cleared Aug 29, 1995
KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEM
K940537 · KWT
Kirschner Medical Corp.
Orthopedic · 568d
Cleared Aug 29, 1995
BECTON DICKINSON BLUNT STEEL CANNULA
K944931 · FMI
Bd Becton Dickinson Vacutainer...
General Hospital · 327d
Cleared Aug 29, 1995
BAIR HUGGER MODEL 600 UNIT, BLANKETS
K950416 · DWJ
Augustine Medical, Inc.
Cardiovascular · 210d
Cleared Aug 29, 1995
EASY PNEUMATIC CROWN AND BRIDGE REMOVER
K951299 · EIS
Dentco, Inc.
Dental · 160d
Cleared Aug 29, 1995
TRIUMPH-1 PORT
K951814 · LJT
Horizon Medical Products, Inc.
General Hospital · 133d
Cleared Aug 29, 1995
CHEMOGUARD, P2 HIRISK
K952274 · FMI
Biosafety Systems, Inc.
General Hospital · 106d
Cleared Aug 29, 1995
ELASTIC IMPRESSION CREAM
K952422 · ELW
Teledyne Water Pik
Dental · 98d
Cleared Aug 29, 1995
CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE
K952562 · DQX
Cardio Metrics, Inc.
Cardiovascular · 88d
Cleared Aug 29, 1995
MEROCEL REINFORCED SILICONE SHEETS
K953013 · KHJ
Merocel Corp.
Ear, Nose, Throat · 61d
Cleared Aug 29, 1995
H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)
K953034 · LKF
Ackrad Laboratories
Obstetrics & Gynecology · 71d
Cleared Aug 29, 1995
LAPPING TOOL KIT
K953103 · DZE
Steri-Oss, Inc.
Dental · 57d
Cleared Aug 29, 1995
QUANTA LITE ACA SCREEN (HRP)
K953291 · MID
Inova Diagnostics, Inc.
Immunology · 46d
Cleared Aug 29, 1995
WYNTEK OSOM HCG-URINE TEST
K953383 · JHI
Wyntek Diagnostics, Inc.
Chemistry · 41d
Cleared Aug 29, 1995
ELLMAN LAPTRODE
K953440 · GCJ
North American Technical Services Corp.
General & Plastic Surgery · 48d
Cleared Aug 29, 1995
PERMUALUTE INDIRECT RESTORATIVE BONDING PRIMERS
K953527 · KLE
Ultradent Products, Inc.
Dental · 33d
Cleared Aug 28, 1995
CENTURY BATHING SYSTEM
K930665 · ILJ
Arjo-Century, Inc.
Physical Medicine · 930d
Cleared Aug 28, 1995
FRIEDRICH ELECTRONIC AIR CLEANER
K944305 · FRF
Friedrich Air Conditioning Co., Inc.
General Hospital · 360d
Cleared Aug 28, 1995
STRYKER STERI-SHIELD SURGICAL APPAREL
K944393 · FYA
Stryker Corp.
General Hospital · 353d
Cleared Aug 28, 1995
DIALYZER REPROCESSING SYSTEM
K944492 · LIF
G.E.M. Water Systems
Gastroenterology & Urology · 349d
Cleared Aug 28, 1995
W&H MICRO AIR MOTOR LT25
K944713 · EFB
A-Dec, Inc.
Dental · 339d
Cleared Aug 28, 1995
MOSS(R) STEEL BREAKAWAY(R) INTRODUCER
K945480 · KOB
Harry A. Schlakman
Gastroenterology & Urology · 293d
Cleared Aug 28, 1995
PRG BUTTON
K946140 · KNT
Applied Medical Technologies
Gastroenterology & Urology · 255d
Cleared Aug 28, 1995
GDLH POSTERIOR SPINAL SYSTEM
K950596 · MNH
Sofamor Danek USA,Inc.
Orthopedic · 200d