FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
90745–90768 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 20, 1998
FACEPLATE ASSEMBLY
K974219 · LRB
Finetone Hearing Instruments
Ear, Nose, Throat · 102d
Cleared Feb 20, 1998
ABUTMENT - COMPLETE
K974280 · DZE
The Implant Center of the Palm Beaches
Dental · 107d
Cleared Feb 20, 1998
CHROMOPHARE D 500, CHROMOPHARE D 530
K974433 · FSY
Berchtold Holding GmbH
General & Plastic Surgery · 88d
Cleared Feb 20, 1998
ANATOM 1000 (A MINUS, A-)
K974455 · JAK
Analogic Corp.
Radiology · 87d
Cleared Feb 20, 1998
VNUS CLOSURE SYSTEM
K974521 · GEI
Vnus Medical Technologies, Inc.
General & Plastic Surgery · 80d
Cleared Feb 20, 1998
ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229
K974816 · LTJ
Beckman Instruments, Inc.
Immunology · 59d
Cleared Feb 20, 1998
NONWOVEN DRESSING
K974823 · KMF
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 58d
Cleared Feb 20, 1998
SIMPLICARE THIN FILM WOUND DRESSINGS
K980209 · MGP
Hollister, Inc.
General & Plastic Surgery · 31d
Cleared Feb 19, 1998
MOBIMED SYSTEM, (PEGASUS AND POLARIS)
K973318 · MSX
Ortivus Us, Inc.
Cardiovascular · 168d
Cleared Feb 19, 1998
LATIS GRAFT CLEANING CATHETER
K973465 · DXE
Applied Medical Resources
Cardiovascular · 160d
Cleared Feb 19, 1998
BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS
K973962 · DSP
C.R. Bard, Inc.
Cardiovascular · 126d
Cleared Feb 19, 1998
VET-CO OTC VACUUM DEVICE/VET-CO CONSTRICTION RING SET
K974215 · LKY
Vetco, Inc.
Gastroenterology & Urology · 101d
Cleared Feb 19, 1998
MLS ELECTROMYOGRAPHIC PREAMPLIFIER
K974385 · IKN
Motion Lab Systems, Inc.
Neurology · 90d
Cleared Feb 19, 1998
KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE...
K974389 · HFN
Clinical Innovations, Inc.
Obstetrics & Gynecology · 90d
Cleared Feb 19, 1998
3.25 MM SIMPLER ONE THREADED DENTAL IMPLANT
K974402 · DZE
Vancouver Implant Resources, Inc.
Dental · 90d
Cleared Feb 19, 1998
3.25MM SIMPLER ONE PUSHIN DENTAL IMPLANT
K974403 · DZE
Vancouver Implant Resources, Inc.
Dental · 90d
Cleared Feb 19, 1998
4.0MM SIMPLER ONE PUSHIN DENTAL IMPLANT
K974404 · DZE
Vancouver Implant Resources, Inc.
Dental · 90d
Cleared Feb 19, 1998
FRIEDL GLIDING NAIL SYSTEM
K974409 · KTT
Plus Orthopedics
Orthopedic · 87d
Cleared Feb 19, 1998
M1730B TRACEMASTER ECG SYSTEM, M1766B LOCAL EDIT STATION, M1798B REMOTE EDIT...
K974420 · DSH
Hewlett-Packard Co.
Cardiovascular · 87d
Cleared Feb 19, 1998
MICHELSON ANTERIOR CERVICAL PLATE SYSTEM
K974435 · KWQ
Wrightmedicaltechnologyinc
Orthopedic · 87d
Cleared Feb 19, 1998
BOSTON ADVANCE CLEANER
K974466 · MRC
Polymer Technology Corp.
Ophthalmic · 85d
Cleared Feb 19, 1998
AESCULAP-MEDITEC SLIT LAMPS SL07 AND SL08
K974467 · HJO
Aesculap-Meditec North America
Ophthalmic · 85d
Cleared Feb 19, 1998
MOISTAIR FLUID AIR TUBING SET
K974561 · KYG
American Medical Devices, Inc.
Ophthalmic · 76d
Cleared Feb 19, 1998
SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER
K974684 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 65d