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
97753–97776 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 17, 1996
NANCY NAIL
K960642 · HTY
Landos, Inc.
Orthopedic · 93d
Cleared May 17, 1996
UNIVERSAL BITE BLOCK
K960663 · JXL
B&B Medical Technologies, Inc.
Neurology · 91d
Cleared May 17, 1996
WALKHALER PORTABLE COMPRESSOR MODEL 45F70
K960675 · CAF
Pari Holding Co.
Anesthesiology · 87d
Cleared May 17, 1996
MICRO21 WITH RETIC
K960776 · JOY
Triangle Biomedical Sciences, Inc.
Hematology · 81d
Cleared May 17, 1996
TEW CRANIAL/SPINAL RETRACTOR MODEL A1090
K960807 · GZT
Ohio Medical Instrument Co., Inc.
Neurology · 79d
Cleared May 17, 1996
QBC ACCUTUBE(423406)/QBC AUTOREAD(424571)
K960827 · GKZ
Becton Dickinson Diagnostic...
Hematology · 78d
Cleared May 17, 1996
MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-CELL,...
K960887 · GKZ
Dako Corp.
Hematology · 74d
Cleared May 17, 1996
WHITESIDE BIOMECHANICS CANCELLOUS BONE SCREW
K961157 · HWC
Whiteside Biomechanics, Inc.
Orthopedic · 56d
Cleared May 17, 1996
BOSWORTH LIQUID RESIN II
K961200 · EBI
Harry J. Bosworth Co.
Dental · 51d
Cleared May 17, 1996
BOSWORTH IMPRESSION MATERIAL II
K961201 · ELW
Harry J. Bosworth Co.
Dental · 51d
Cleared May 17, 1996
PHONAK PICONET2 P2 AZ
K961622 · ESD
Phonak, Inc.
Ear, Nose, Throat · 21d
Cleared May 17, 1996
CYTOQUANT CHLAMYDIA TRANSPORT MEDIUM
K961755 · JSN
Proteins Intl., Inc.
Microbiology · 11d
Cleared May 17, 1996
CYTOQUANT VIRAL TRANSPORT MEDIUM
K961756 · JSN
Proteins Intl., Inc.
Microbiology · 11d
Cleared May 16, 1996
MAGNES II BIOMAGNETOMETER
K941553 · OLX
Biomagnetic Technologies, Inc.
Neurology · 778d
Cleared May 16, 1996
BIOTRACE-N, NS, 410 AND RT
K944496 · DRX
Msb , Ltd.
Cardiovascular · 611d
Cleared May 16, 1996
KARL STORZ RIGID TELESCOPES FOR OBSTERICS AND GYNECOLOGY
K950335 · HET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 475d
Cleared May 16, 1996
MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS)
K953434 · HBB
Midas Rex Pneumatic Tools, Inc.
Neurology · 300d
Cleared May 16, 1996
LARKEL DEVICE WITH ATTACHMENTS A-H(MODIFICATION)
K953559 · BTO
Seidel Medizin GmbH
Anesthesiology · 331d
Cleared May 16, 1996
BERLIN EXTERNAL FIXATOR
K954053 · LXT
Encore Orthopedics, Inc.
Orthopedic · 261d
Cleared May 16, 1996
CONMED ECG/EKG ELECTRODES
K954389 · DRX
Conmedcorp
Cardiovascular · 240d
Cleared May 16, 1996
SPECTACLE FRAMES/SUNGLASSES
K954419 · HQY
Ami Fashion
Ophthalmic · 238d
Cleared May 16, 1996
CRICKET
K955304 · DQX
Microvena Corp.
Cardiovascular · 178d
Cleared May 16, 1996
PMMA CLASIC
K955777 · HPX
Rand Scientific Corp.
Ophthalmic · 148d
Cleared May 16, 1996
SLT FUMICH PROBE GUIDE
K960821 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 77d