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
133153–133176 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 29, 1988
CERVICAL BIOPSY INSTRUMENT
K883867 · HEB
Mend Technologies, Inc.
Obstetrics & Gynecology · 77d
Cleared Nov 29, 1988
TRANSESOPHAGEAL ECHO TRANSDUCER
K883889 · JOP
General Electric Co.
Cardiovascular · 76d
Cleared Nov 29, 1988
DU PONT DIMENSION PSEUDOCHOLINESTERASE METHOD
K883890 · DIH
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 76d
Cleared Nov 29, 1988
DU PONT DIMENSION PSEUDOCHOLINESTERASE VERIFIER
K883891 · LAS
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 76d
Cleared Nov 29, 1988
ROCHE REAGENT FOR INORGANIC PHOSPHORUS
K883962 · CEO
Roche Diagnostic Systems, Inc.
Chemistry · 70d
Cleared Nov 29, 1988
ABBOTT IMX LH
K884138 · CEP
Abbott Laboratories
Chemistry · 60d
Cleared Nov 29, 1988
ANALYST THYROXINE (T4) & THYRONINE UPTAKE CALIBRA.
K884168 · JIS
The DU Pont Co.
Chemistry · 56d
Cleared Nov 29, 1988
LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD
K884362 · HQJ
Bausch & Lomb Pharmaceutical, Inc.
Ophthalmic · 40d
Cleared Nov 29, 1988
LABELING CHANGES TO BIO-COR II COLLANGEN CORNEAL
K884363 · MOE
Bausch & Lomb Pharmaceutical, Inc.
Ophthalmic · 40d
Cleared Nov 29, 1988
LABELING CHANGES TO BIO-COR EXT COLLANGEN CORNEAL
K884364 · MOE
Bausch & Lomb Pharmaceutical, Inc.
Ophthalmic · 40d
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