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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
107017–107040 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 08, 1994
BIOSCAN REAGENT STRIPS
K943008 · JJB
Genesis Labs, Inc.
Toxicology · 45d
Cleared Aug 05, 1994
CERAMIC(TM) ABUTMENT
K913255 · DZE
Ceramic Core Corp.
Dental · 1124d
Cleared Aug 05, 1994
FILTRAL HEMODIALYZERS
K920757 · KDI
C.G.H. Medical, Inc.
Gastroenterology & Urology · 898d
Cleared Aug 05, 1994
BROWNE TST SINGLE USE BOWIE DICK TYPE TEST PACK
K932057 · JOJ
Board of Directors, Albert Browne , Ltd.
General Hospital · 464d
Cleared Aug 05, 1994
MESIAL LOOP BAR
K933542 · ECO
Gac Intl., Inc.
Dental · 381d
Cleared Aug 05, 1994
LINE EXTENSION FOR KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM, POROUS COATED
K933843 · JWH
Kirschner Medical Corp.
Orthopedic · 364d
Cleared Aug 05, 1994
SLIP-ON FIXATION SPLINT (SFS)
K934468 · EHO
Gatewood Splints
Dental · 329d
Cleared Aug 05, 1994
BVR HIGH TORQUE HEADS
K934781 · EGS
Bvr Aero Precision Corp.
Dental · 304d
Cleared Aug 05, 1994
FLOW DIRECTED MIKRO-TIP PRESSURE TRANSDUCER
K935166 · DXO
Millar Instruments, Inc.
Cardiovascular · 282d
Cleared Aug 05, 1994
STICKIT
K935407 · FMI
E.M. Innovations, Inc.
General Hospital · 269d
Cleared Aug 05, 1994
BASICS ENDOSCOPY SYSTEM
K941464 · OCZ
Cox Medical Ent., Inc.
Gastroenterology & Urology · 130d
Cleared Aug 05, 1994
STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH
K941605 · LXH
Stryker Corp.
Orthopedic · 126d
Cleared Aug 05, 1994
DIB INFUSOR
K941766 · MEB
Novacon Corp.
General Hospital · 116d
Cleared Aug 05, 1994
THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE
K941938 · HCC
Intercare Diagnostics, Inc.
Neurology · 106d
Cleared Aug 05, 1994
POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K942042 · LYZ
Cheer & Merit Co., Ltd.
General Hospital · 99d
Cleared Aug 05, 1994
IRRIGATION TRAY WITH PISTON SYRINGE
K942221 · FMF
Trinity Laboratories, Inc.
General Hospital · 91d
Cleared Aug 05, 1994
ADDVANTAGE 38 ASPHERIC SOFT CONTACT LENS
K942302 · LPL
Preferred Optics, Inc.
Ophthalmic · 85d
Cleared Aug 05, 1994
HYDRO-S WOUND GEL
K942419 · MGQ
Hymedix Intl., Inc.
General & Plastic Surgery · 77d
Cleared Aug 05, 1994
ALTAIR 6100 CASSETTE RECORDER
K942438 · DSH
Burdick, Inc.
Cardiovascular · 77d
Cleared Aug 05, 1994
ENDOPATH
K942450 · GBZ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 74d
Cleared Aug 05, 1994
VISARD FRAMES
K942478 · HQZ
Iris Optical, Inc.
Ophthalmic · 72d
Cleared Aug 05, 1994
SCIPOTEX POWDER FREE EXAM GLOVES (UNBEADED)
K942510 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 71d
Cleared Aug 05, 1994
INTEGRAPOST
K942528 · ELR
Dental Logics, Inc.
Dental · 70d
Cleared Aug 05, 1994
NOVALENS/NOVAWET PERCEPTION AND VANGUARD
K942533 · HQD
Ocutec Corporation, Inc.
Ophthalmic · 70d