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
134257–134280 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 19, 1988
HR-2000 W/SUFFIXES B,C,D, CARDIO & DIGI LOOP, DDVP
K882175 · JAA
Eigen
Radiology · 87d
Cleared Aug 19, 1988
LUHR MICRO SYSTEM
K882454 · HRS
Howmedica Corp.
Orthopedic · 66d
Cleared Aug 19, 1988
ATH METAL:UHMWPE TOTAL HIP SYSTEM
K882675 · KWA
Kinamed, Inc.
Orthopedic · 52d
Cleared Aug 19, 1988
THE BERG RESUSCITATION APPARATUS
K882833 · BTL
Hursch Ent., Inc.
Anesthesiology · 42d
Cleared Aug 19, 1988
MECHANICAL TABLES AND ACCESSORIES
K882900 · INW
Rifton
Physical Medicine · 39d
Cleared Aug 19, 1988
DENTASCAN
K882906 · JAK
Mpdi, Inc.
Radiology · 38d
Cleared Aug 19, 1988
MEDA ONE-STEP
K882943 · GZJ
Medical Electronic Assn.
Neurology · 39d
Cleared Aug 19, 1988
LARYNGOSCOPE BLADES
K883414 · CCW
Truphatek, Ltd.
Anesthesiology · 4d
Cleared Aug 18, 1988
THE VENUS SYSTEM
K880773 · GWL
Neuroscientific Corp.
Neurology · 174d
Cleared Aug 18, 1988
ENDOVAGINAL PROBE, SMS-510VA
K882959 · IYO
Toshiba Medical Systems
Radiology · 35d
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