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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
140641–140664 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 1987
SPOTTEST PYR REAGENT
K870449 · JTO
Difco Laboratories, Inc.
Microbiology · 23d
Cleared Feb 26, 1987
QUICKIE RX PRESCRIPTION WHEELCHAIR
K870476 · IOR
Motion Designs, Inc.
Physical Medicine · 23d
Cleared Feb 26, 1987
CULTURIA MACCONKEY-MUG/MODIFIED TSA SYSTEMS
K870502 · JSI
Clinical Convenience Products, Inc.
Microbiology · 22d
Cleared Feb 26, 1987
DANNIFLEX 400I
K870510 · BXB
Buckman Co., Inc.
Physical Medicine · 21d
Cleared Feb 26, 1987
KODAK X-OMATIC IDENT. CAMERA, MODELS 2 AND 2L
K870565 · JAC
Eastman Kodak Company
Radiology · 16d
Cleared Feb 26, 1987
ELEVATOR, COBB SPINAL
K870591 · GEG
Military Engineering, Inc.
General & Plastic Surgery · 16d
Cleared Feb 26, 1987
KODAK X-OMATIC IDENTIFICATION CAMERA DIGITAL
K870701 · JAC
Eastman Kodak Company
Radiology · 6d
Cleared Feb 26, 1987
SKAN D-SCOPE
K870703 · IYX
Medx, Inc.
Radiology · 6d
Cleared Feb 25, 1987
DOPPLER UNIT, SDS-100A
K863577 · IYN
Toshiba Medical Systems
Radiology · 166d
Cleared Feb 25, 1987
SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22
K863609 · FKP
International Medical Products, Inc.
Gastroenterology & Urology · 162d
Cleared Feb 25, 1987
MPX SYSTEM, GLUCOSE TEST SYSTEM
K864322 · CGA
Lifescan, Inc.
Chemistry · 114d
Cleared Feb 25, 1987
710 PLUS
K864557 · JQP
Ciba Corning Diagnostics Corp.
Chemistry · 98d
Cleared Feb 25, 1987
DZIDRA GLASS FOR USE IN DENTISTRY
K864655
Glen Whitten, Dds
Neurology · 89d
Cleared Feb 25, 1987
DZIDRA GLASS FOR USE IN OPHTHALMOLOGY
K864656
Glen Whitten, Dds
Neurology · 89d
Cleared Feb 25, 1987
DZIDRA GLASS FOR USE IN NEUROLOGY
K864678
Glen Whitten, Dds
Neurology · 85d
Cleared Feb 25, 1987
DZIDRA GLASS FOR USE IN GENERAL MEDICAL
K864679
Glen Whitten, Dds
Neurology · 85d
Cleared Feb 25, 1987
SR 3/60 NF DENTURE MATER. & SELF-CURE DENT. RESIN
K864708 · EBI
Ivoclar USA, Inc.
Dental · 85d
Cleared Feb 25, 1987
AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT
K864855 · JLS
Amersham Corp.
Chemistry · 76d
Cleared Feb 25, 1987
MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT SPECI. TEST
K864888 · LJP
Syva Co.
Microbiology · 75d
Cleared Feb 25, 1987
INSTRUCTION CHANGE FOR RIGHT ATRIAL/RAAF CATHETER
K864949 · FOZ
Quinton, Inc.
General Hospital · 82d
Cleared Feb 25, 1987
LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM FOR (ENT)
K864975 · EWG
Laserscope
Ear, Nose, Throat · 65d
Cleared Feb 25, 1987
OSSEOINTEGRATED FIXTURES FOR USE IN DENTAL IMPLANT
K864995 · DZE
Vent-Plant Corporation, Inc.
Dental · 65d
Cleared Feb 25, 1987
THERMAL JACKET FOR I.V. FLUID BAGS
K870113 · KPE
Thermal Medical Systems, Inc.
General Hospital · 44d
Cleared Feb 25, 1987
MODIFIED BIO. HEMODIALYSIS & HD-1000 DISP. CART.
K870270 · FKT
Ash Medical Systems, Inc.
Gastroenterology & Urology · 29d