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
107593–107616 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 01, 1994
E-Z-FLATE
K930581 · FCX
E-Z-Em, Inc.
Gastroenterology & Urology · 512d
Cleared Jul 01, 1994
SANITAS WHIRPOOL BATHING SYSTEM
K930624 · ILJ
Dutton-Lainson Co.
Physical Medicine · 508d
Cleared Jul 01, 1994
ELECTRO-MESH
K932299 · GXY
Prizm Medical, Inc.
Neurology · 416d
Cleared Jul 01, 1994
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR
K932897 · GZJ
Nemectron GmbH
Neurology · 382d
Cleared Jul 01, 1994
BIVONA NASAL TURBINATE STENT
K935053 · LYA
Bivona Medical Technologies
Ear, Nose, Throat · 253d
Cleared Jul 01, 1994
VX4 RECORDING PULSE OXIMETER
K935510 · DQA
Vitalog Monitoring,Inc.
Anesthesiology · 227d
Cleared Jul 01, 1994
4002 INFANT SCALE FOR INCUBATORS AND WARMERS
K935609 · FMT
Scale-Tronix, Inc.
General Hospital · 224d
Cleared Jul 01, 1994
DISSECTORS, FORCEPS, SCISSORS, DILATION SETS, AND GALL STONE COLLECTORS
K936262 · GCJ
Medicon Instruments, Inc.
General & Plastic Surgery · 183d
Cleared Jul 01, 1994
HAND ANEROID SPHYGMOMANOMETER
K940493 · DXQ
Welch Allyn, Inc.
Cardiovascular · 149d
Cleared Jul 01, 1994
DOUBLE TRACH SWIVEL CONNECTOR
K940793 · BZA
Seven Harvest Intl. Import & Export
Anesthesiology · 129d
Cleared Jul 01, 1994
SURGISTAR TROCARS
K941747 · GCJ
Surgistar, Inc.
General & Plastic Surgery · 84d
Cleared Jul 01, 1994
ULTRACISON HARMONIC SCALPEL HS2 BLADE
K941897 · GEI
Ultracision, Inc.
General & Plastic Surgery · 74d
Cleared Jul 01, 1994
HMT ENDOSCREEN, MODEL ESC 501
K942155 · FCW
Servicetrends, Inc.
Gastroenterology & Urology · 59d
Cleared Jul 01, 1994
MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEM
K942233 · EPT
Carl Zeiss, Inc.
General & Plastic Surgery · 53d
Cleared Jul 01, 1994
ZEISS OPMILAS 144 SURGICAL LASERS
K942439 · GEX
Zeiss Humphrey System
General & Plastic Surgery · 112d
Cleared Jul 01, 1994
INSULATED SURGICAL ELECTRODE
K942499 · GEI
Springfield Surgical Instruments
General & Plastic Surgery · 38d
Cleared Jul 01, 1994
PSB PREPERITONEAL STRUCTURE BALLOON
K942636 · GCJ
Origin Medsystems, Inc.
Ophthalmic · 28d
Cleared Jun 30, 1994
IRRIGATION PUMP AND TUBING SET
K924611 · HET
Marlo Surgical Technology
Obstetrics & Gynecology · 657d
Cleared Jun 30, 1994
MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONS
K924875 · BZQ
Synectics-Dantec
Anesthesiology · 654d
Cleared Jun 30, 1994
NO CROSS CONTAM HYDROTHERAPY TANK LINER
K930096 · ILJ
Land and Sky Mfg., Inc.
Physical Medicine · 538d
Cleared Jun 30, 1994
STRYKER ARTHROSCOPIC ACCESSORIES
K930224 · GCJ
Stryker Corp.
General & Plastic Surgery · 531d
Cleared Jun 30, 1994
THE CABOT MEDICAL INSUL-SHETH VAGINAL SPECULUM COV
K930954 · HIB
Cabot Medical Corp.
Obstetrics & Gynecology · 492d
Cleared Jun 30, 1994
VINYL EXAMINATION GLOVES
K932054 · LYZ
Assured Medical Supply Co., Ltd.
General Hospital · 430d
Cleared Jun 30, 1994
ORTHOLOC ADVANTIM L.S. TIBIAL COMPONENT
K932911 · JWH
Dow Corning Wright
Orthopedic · 379d