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
134857–134880 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 18, 1988
SITE STERILIZATION TRAYS FOR OPHTHALMIC USE
K883098 · LRP
Site Microsurgical Systems, Inc.
General & Plastic Surgery · 27d
Cleared Aug 18, 1988
SAFECRIT PLASTIC MICROHEMATOCRIT TUBES
K883185 · GHY
Norfolk Scientific, Inc.
Hematology · 21d
Cleared Aug 18, 1988
CANON AUTOREFRACTOMETER R-22
K883200 · HKO
Canon USA, Inc.
Ophthalmic · 21d
Cleared Aug 18, 1988
BUNN MODEL 50 OXYGEN FLOW CONTROLLER
K883216 · NFB
The John Bunn Co.
Anesthesiology · 20d
Cleared Aug 18, 1988
SONICATOR 720 (MODEL ME720)
K883228 · IMI
Mettler Electronics Corp.
Physical Medicine · 17d
Cleared Aug 18, 1988
SWEDE ELITE, MECHANICAL WHEELCHAIR
K883275 · IOR
Etac Us, Inc.
Physical Medicine · 15d
Cleared Aug 18, 1988
CLIPPER POWER DRIVE WHEELCHAIR
K883339 · ITI
Everest & Jennings, Inc.
Physical Medicine · 9d
Cleared Aug 17, 1988
PLATELIN(R) EXCEL L
K881999 · GIT
Organon Teknika Corp.
Hematology · 97d
Cleared Aug 17, 1988
SLT CONTACT LASER SYSTEM
K882212 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 83d
Cleared Aug 17, 1988
STORZ DISPOSABLE BIPOLAR PENCILS
K882802 · GXI
Storz Instrument Co.
Neurology · 41d
Cleared Aug 17, 1988
SCEPTOR NEW ANTIMICROBIAL AGENT: AMPICILLIN/SULBAC
K882910 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 36d
Cleared Aug 17, 1988
SCEPTOR EXTEN. OF CONCENTRATION RANGE: PENCILLIN
K882911 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 36d
Cleared Aug 17, 1988
SCEPTOR NEW ANTIMICROBIAL AGENT: IMIPENEM
K882912 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 36d
Cleared Aug 17, 1988
DIMERTEST(R) LATEX
K882944 · DAP
Agen Biomedical , Ltd.
Hematology · 34d
Cleared Aug 17, 1988
ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION
K883048 · LDZ
Alpha-Tec Systems, Inc.
Pathology · 32d
Cleared Aug 17, 1988
ATS PARA-SET IODINE ALCOHOL SOLUTION
K883049 · JTS
Alpha-Tec Systems, Inc.
Pathology · 29d
Cleared Aug 17, 1988
ATS PARA-SET CARBOL-XYLENE SOLUTION
K883061 · JTS
Alpha-Tech Systems, Inc.
Pathology · 29d
Cleared Aug 16, 1988
STAR CALC
K875027 · BZC
Infrasonics Corp.
Anesthesiology · 253d
Cleared Aug 16, 1988
PLEUR-EVAC-A-7000--ADULT/PEDI CHEST DRAINAGE SYST
K882223 · KDQ
Deknatel, Inc.
General Hospital · 82d
Cleared Aug 16, 1988
AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS
K882229 · IOQ
Biologics Intl., Inc.
Physical Medicine · 88d
Cleared Aug 16, 1988
NONREBREATHING CIRCUIT
K882285 · BTM
Dryden Corp.
Anesthesiology · 76d
Cleared Aug 16, 1988
LASER LARYNGOSCOPE DEDO ARTICULA. & FEDER DEDO EX
K882930 · CCW
Pilling Co.
Anesthesiology · 34d
Cleared Aug 16, 1988
L-F/KODAK FLEXIBLE GRID CASSETTE
K883312 · IXA
Mallinckrodt Group, Inc.
Radiology · 11d
Cleared Aug 15, 1988
3 PHASE HIGH FREQ. DIAG. X-RAY GEN. MICRO-X 60HF
K880525 · IZO
Fischer Imaging Corp.
Radiology · 188d