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
134185–134208 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 26, 1988
LQ1106 OPHTHALMIC YAG LASER
K882772 · GEX
Keeler Instruments, Inc.
General & Plastic Surgery · 51d
Cleared Aug 26, 1988
ORAL-B FLOSSERS
K883024 · JES
Oral-B Laboratories
Dental · 38d
Cleared Aug 26, 1988
STERI-CLENS WOUND CARE KIT
K883250 · LRO
Absorbent Cotton Co., Inc.
General & Plastic Surgery · 24d
Cleared Aug 26, 1988
MENTOR RAPID-SPAN (TM) TISSUE EXPANDER
K883303 · FZW
Mentor Corp.
General & Plastic Surgery · 22d
Cleared Aug 26, 1988
DENTAL HAND INSTRUMENTS
K883322 · EKJ
Collagen Corp.
Dental · 21d
Cleared Aug 26, 1988
COLGATE DENTAL FLOSS
K883335 · JES
Colgate-Palmolive Co.
Dental · 17d
Cleared Aug 26, 1988
LANCET, BLOOD
K883420 · FMK
Primrose Medical, Inc.
General & Plastic Surgery · 11d
Cleared Aug 26, 1988
ASST-3000 SPINAL SURGERY TABLE
K883457 · FWY
Orthopedic Systems, Inc.
General & Plastic Surgery · 14d
Cleared Aug 26, 1988
SURGICAL SHIRT
K883464 · FYA
Arkansas Lighthouse For the Blind
General Hospital · 11d
Cleared Aug 25, 1988
HYBRIWICK SYSTEM: HERPES DNA PROBE TEST KIT
K873529 · GQN
Diagnostic Hybrids, Inc.
Microbiology · 359d
Cleared Aug 25, 1988
GPS/WGPS/PREVIEW GP
K874854 · IYO
Labsonics, Inc.
Radiology · 272d
Cleared Aug 25, 1988
HYSTEROSCOPE AUTONOM 4992
K880314 · HIH
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 212d
Cleared Aug 25, 1988
XACT NEISSERIA
K880511 · JSX
Austin Biological Laboratories
Microbiology · 198d
Cleared Aug 25, 1988
VESSEL DILATOR AND INTRODUCER SHEATH
K882238 · DRE
Ideal Medical, Inc.
Cardiovascular · 90d
Cleared Aug 25, 1988
HORIZON 2000 PULSE OXIMETRY AND MODULE
K882273 · DQA
Mennen Medical, Inc.
Anesthesiology · 86d
Cleared Aug 25, 1988
UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
K882325 · GFO
Sclavo, Inc.
Hematology · 80d
Cleared Aug 25, 1988
STIHLER ASTOTHERM IFT 200, IFT 220
K882361 · LGZ
Stihler Electronic, C/O Worldwide...
General Hospital · 79d
Cleared Aug 25, 1988
METATECH MICROCLIP APPLICATOR
K882367 · DWS
Metatech Corp.
Cardiovascular · 78d
Cleared Aug 25, 1988
SYSMEX K-1000 18 PARAMETER, AUTO. HEMA ANALYZER
K882370 · GKZ
Toa Medical Electronics USA, Inc.
Hematology · 78d
Cleared Aug 25, 1988
COAG-I ANALYZER, ALPHA MODEL
K882444 · JPA
Cardiovascular Diagnostic Services
Hematology · 72d
Cleared Aug 25, 1988
MEDTRONIC MODELS 4057/4557 ENDOCARDIAL PACING LEAD
K882452 · DTB
Medtronic Vascular
Cardiovascular · 72d
Cleared Aug 25, 1988
COAG-I PT TEST CARD
K882456 · GJS
Cardiovascular Diagnostic Services
Hematology · 72d
Cleared Aug 25, 1988
30 IV EXTENSION SET W/TWO MALE LUER LOCKS
K882503 · FPA
Churchill Medical Systems, Inc.
General Hospital · 69d
Cleared Aug 25, 1988
MULTIPLE SPECTACLE FRAMES
K883100 · HQZ
Metal Optics U.S.A., Inc.
Ophthalmic · 34d