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
103369–103392 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 13, 1995
CLINICAL VOICE THERMOMETER
K935466 · FLL
Blazie Engineering, Inc.
General Hospital · 517d
Cleared Apr 13, 1995
COMFIT PINK POWDERED EXAMINATION GLOVES (HYPOALLERGENIC)
K936266 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 469d
Cleared Apr 13, 1995
BONE PLATE SYSTEM
K942359 · HRS
Acu Med, Inc.
Orthopedic · 331d
Cleared Apr 13, 1995
ALLURE (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT LENS
K942374 · LPL
Sunsoft Corp.
Ophthalmic · 330d
Cleared Apr 13, 1995
DATUM
K942799 · CAD
Blease USA, Inc.
Anesthesiology · 302d
Cleared Apr 13, 1995
FLEXIFLO SIX ENTERAL NUTRITION PUMP SET
K943240 · KNT
Abbott Laboratories
Gastroenterology & Urology · 281d
Cleared Apr 13, 1995
SPINAL MARKER
K944188 · LXH
Leibinger L.P.
Orthopedic · 230d
Cleared Apr 13, 1995
BRANEMARK SYSTEM(R) MKII SELF-TAPPING FIXTURE
K945398 · DZE
Nobelpharma USA, Inc.
Dental · 161d
Cleared Apr 13, 1995
ABUSIGN(TM) AMP, DOA-AMP, ACCUSIGN(TM) AMP-DOA-AMP, BIOSIGN(TM) AMP, DOA-AMP
K945610 · DKZ
Princeton BioMeditech Corp.
Toxicology · 149d
Cleared Apr 13, 1995
BELTONE COMPARAFIT
K946340 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 105d
Cleared Apr 13, 1995
ENDOSCOPIC LIGATION DEVICE, LIGATOR HANDLE, LIGATOR CARTRIDGE
K950126 · GCJ
Advanced Surgical, Inc.
General & Plastic Surgery · 91d
Cleared Apr 13, 1995
HYPODERMIC SYRINGE PISTON
K950133 · FMF
Ispg, Inc.
General Hospital · 90d
Cleared Apr 13, 1995
URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE
K950137 · DIS
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 90d
Cleared Apr 13, 1995
PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR
K950164 · CHH
Abaxis, Inc.
Chemistry · 86d
Cleared Apr 13, 1995
TACTYLON(TM) POWDER FREE SURGEONS GLOVE
K950185 · KGO
Tactyl Technologies, Inc.
General Hospital · 86d
Cleared Apr 13, 1995
ELSA-PTH
K950211 · CEW
Cis-Us, Inc.
Chemistry · 84d
Cleared Apr 13, 1995
A2 DETACHED DUAL PORT SYSTEM
K950212 · LJT
Therex Corp.
General Hospital · 84d
Cleared Apr 13, 1995
MESH MATRIX WOUND DRESSING
K950281 · KGN
Brennen Medical, Inc.
General & Plastic Surgery · 79d
Cleared Apr 13, 1995
DEVICE, ELECTROSURGICAL, CUTTING AND COAGULATION & ACCESSORIES
K950406 · GEI
Aaron Medical Industries
General & Plastic Surgery · 72d
Cleared Apr 13, 1995
IMPLANTABLE CLIP
K950540 · FZP
United States Surgical, A Division of...
General & Plastic Surgery · 65d
Cleared Apr 13, 1995
ULTRACELL RETRACTOR COVERS
K950659 · GDY
Ultracell Medical Technologies, Inc.
General & Plastic Surgery · 59d
Cleared Apr 13, 1995
ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAIN
K950677 · KDQ
Atrium Medical Corp.
General Hospital · 58d
Cleared Apr 13, 1995
MODUILAR UNIPOLAR
K950998 · KXA
Intermedics Orthopedics
Orthopedic · 41d
Cleared Apr 13, 1995
AURA LASER SYSTEM
K951034 · GEX
Laserscope
General & Plastic Surgery · 38d