FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
133753–133776 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 29, 1988
TECHNICON ASSIST(R) CALCIUM METHOD
K884433 · CIC
Technicon Instruments Corp.
Chemistry · 39d
Cleared Nov 29, 1988
BIOTROL BILIRUBIN MONOREACTIF
K884480 · CIC
Biotrol, USA, Inc.
Chemistry · 35d
Cleared Nov 28, 1988
MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDES
K882383 · DWZ
CIVCO Medical Instruments Co., Inc.
Cardiovascular · 172d
Cleared Nov 28, 1988
O2 CARE
K882461 · KPJ
Ballard Medical Products
General & Plastic Surgery · 166d
Cleared Nov 28, 1988
MULTIICHALLENGE NEBULIZER SYSTEM
K883704 · BTI
Biotrine Corp.
Anesthesiology · 90d
Cleared Nov 28, 1988
HP-1 (HEALTHPAX)
K883812 · QJQ
Healthdirections, Inc.
Neurology · 81d
Cleared Nov 28, 1988
MODEL NS242 CONSTANT CURRENT PERIPHERAL NERVE STIM
K883868 · BXN
Fisher & Paykel Electronics , Ltd.
Anesthesiology · 76d
Cleared Nov 28, 1988
POSTERIOR CERVICAL SPINE SURFACE COIL M1085AM
K884369 · LNH
General Electric Co.
Radiology · 41d
Cleared Nov 28, 1988
TRACER HIP PINNING SYSTEM
K884406 · JDS
De Medica Mfg., Inc.
Orthopedic · 40d
Cleared Nov 28, 1988
TRACER SKELETAL TRACTION PINS
K884407 · HSB
De Medica Mfg., Inc.
Orthopedic · 40d
Cleared Nov 25, 1988
OCCU-TECH VISION TEST
K881971 · HOX
Applied Vision Concepts, Inc.
Ophthalmic · 198d
Cleared Nov 25, 1988
PALMA
K882639 · KGO
Kelso Imports
General Hospital · 151d
Cleared Nov 25, 1988
ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT
K883372 · JAA
Ausonics Pty , Ltd.
Radiology · 107d
Cleared Nov 25, 1988
STERILE SURGICAL GLOVES
K883466 · KGO
Cal-American Exports, Inc.
General Hospital · 102d
Cleared Nov 25, 1988
KTP/532 SURGICAL LASER
K884029 · GEX
Laserscope
General & Plastic Surgery · 63d
Cleared Nov 25, 1988
DISPOSABLE BIPOLAR CORD AND BIPOLAR FORCEP
K884656 · GEI
Dermacare
General & Plastic Surgery · 18d
Cleared Nov 23, 1988
POLYSCAN DIGITAL SCANNER
K882453 · IYW
Medical and Scientific Enterprises, Inc.
Radiology · 162d
Cleared Nov 23, 1988
ULTRASONIC IMAGING CATHETER
K883202 · DXO
Boston Scientific Corp
Cardiovascular · 118d
Cleared Nov 23, 1988
VOXEL FLINGER(TM) 3-D IMAGING SYSTEM
K883476 · LLZ
Reality Imaging Corp.
Radiology · 99d
Cleared Nov 23, 1988
BERICHROM(R) ANTITHROMBIN III
K883662 · JBQ
Behring Diagnostics, Inc.
Hematology · 89d
Cleared Nov 23, 1988
MAGNETOM (M, H, 42, 63) SEQUENCES
K884062 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 58d
Cleared Nov 23, 1988
DISKCAM DC 6001
K884148 · LMB
Camtronics, Ltd.
Radiology · 51d
Cleared Nov 23, 1988
NIDEK LM-870 AUTOMATIC LENSMETER
K884188 · HLM
Nidek, Inc.
Ophthalmic · 49d
Cleared Nov 23, 1988
NICOLET NYSTAR PLUS SYSTEM
K884294 · GWN
Nicolet Instrument Corp.
Neurology · 42d