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
88873–88896 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 25, 1998
MT-200
K973751 · DQK
Schiller America, Inc.
Cardiovascular · 328d
Cleared Aug 25, 1998
MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE
K974220 · DPS
Micromedical, Inc.
Cardiovascular · 286d
Cleared Aug 25, 1998
ONE UP DISPOSABLE KERATOME HEAD
K981742 · HNO
Moria, Inc.
Ophthalmic · 99d
Cleared Aug 25, 1998
ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA
K981801 · LFH
Princeton BioMeditech Corp.
Toxicology · 96d
Cleared Aug 25, 1998
CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY AND ELECSYS...
K981931 · CGN
Roche Diagnostics/Boehringer Mannheim...
Chemistry · 84d
Cleared Aug 25, 1998
THE WAVE DIGITAL PHACO SYSTEM
K981989 · HQC
Circuit Tree
Ophthalmic · 81d
Cleared Aug 25, 1998
STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)
K982061 · DIO
OraSure Technologies, Inc.
Toxicology · 82d
Cleared Aug 25, 1998
ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES
K982429 · PSZ
Zymetx, Inc.
Microbiology · 43d
Cleared Aug 25, 1998
C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK)
K982442 · IZD
Care Wise Medical Products Corp.
Radiology · 42d
Cleared Aug 25, 1998
DIMENSION(R) VALPROIC (VALP) ACID METHOD
K982880 · LEG
Dade Behring, Inc.
Toxicology · 11d
Cleared Aug 24, 1998
MAGELLAN
K961903 · HAW
Biosense, Ltd.
Neurology · 830d
Cleared Aug 24, 1998
PEGASUS ND:YAG LASER SYSTEM
K980559 · GEX
Premier Laser Systems, Inc.
General & Plastic Surgery · 192d
Cleared Aug 24, 1998
EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A)
K980725 · CBP
Instrumentation Industries, Inc.
Anesthesiology · 181d
Cleared Aug 24, 1998
COBE CLOSED VENOUS RESERVOIR BAGS WITH SMARX T, MODELS VRB 1200 AND VRB 1800
K980786 · DTN
Cobe Cardiovascular, Inc.
Cardiovascular · 175d
Cleared Aug 24, 1998
ADDIQUIP DISPOSABLE ACUPUNCTURE NEEDLES
K981272 · MQX
Electro Therapeutic Devices, Inc.
General Hospital · 139d
Cleared Aug 24, 1998
SUCTION CATHETER
K981910 · BSY
Ni-Med, Inc.
Anesthesiology · 84d
Cleared Aug 24, 1998
THE SNORE PEACE
K981923 · LRK
The Snore Peace Group
Dental · 84d
Cleared Aug 24, 1998
WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM
K981937 · EIA
Welch Allyn, Inc.
Dental · 83d
Cleared Aug 24, 1998
BREATHERITE
K981944 · CAF
Ventlab Corp.
Anesthesiology · 82d
Cleared Aug 24, 1998
TBIRD VS/AVS VOLUME VENTILATOR, MODELS 15568, 15570 , LP10 VOLUME VENTILATOR...
K981971 · CBK
Bird Products Corp.
Anesthesiology · 81d
Cleared Aug 24, 1998
REACH HIP COMPONENT
K982367 · LPH
Biomet, Inc.
Orthopedic · 48d
Cleared Aug 24, 1998
CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS
K982369 · FYC
Allegiance Healthcare Corp.
General Hospital · 48d
Cleared Aug 24, 1998
MITEK MICRO ANCHOR
K982420 · JDR
Mitek Products
Orthopedic · 70d
Cleared Aug 24, 1998
AMALCAP PLUS
K982456 · EJJ
Ab Ardent
Dental · 40d