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
96601–96624 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 26, 1996
ACRYLIC READING AND POLYCARBONATE LENSES SUNGLASSES
K962279 · HQY
Jane Fui Optical Co., Ltd.
Ophthalmic · 74d
Cleared Aug 26, 1996
RAVEN EYE, INC.- EYE WEAR
K962940 · HQY
Raven Eye, Inc.
Ophthalmic · 28d
Cleared Aug 26, 1996
LINEA MILANO SUNGLASSES, KALEIDO SUNGLASSES PLASTIC AND METAL FRAMES
K963083 · HQY
Piazza Optical Corp.
Ophthalmic · 18d
Cleared Aug 26, 1996
RAVEN EYE- EYE WEAR (SUNGLASSES)
K963284 · HQY
Raven Eye, Inc.
Ophthalmic · 28d
Cleared Aug 23, 1996
AXSYM TOXO IGM
K954576 · LGD
Abbott Laboratories
Microbiology · 326d
Cleared Aug 23, 1996
RETICULOCYTE METHOD, RBC INDICES
K954594 · GKZ
Bayer Corp.
Hematology · 325d
Cleared Aug 23, 1996
CADD-PRIZM MODEL 6100 PUMP
K960826 · FRN
Sims Deltec, Inc.
General Hospital · 176d
Cleared Aug 23, 1996
OREX SURGEON'S VEST
K961083 · FYA
Thantex Specialties, Inc.
General Hospital · 157d
Cleared Aug 23, 1996
BENZ 38 CLEAR & WITH BLUE VISIBILITY TINT
K961103 · LPL
Benz Research and Development Corp.
Ophthalmic · 156d
Cleared Aug 23, 1996
MODEL 1200 ABMULATORY INFUSION PUMP
K961263 · FRN
Patient Solutions, Inc.
General Hospital · 143d
Cleared Aug 23, 1996
HEMOCUE B-GLUCOSE SYSTEM
K961311 · LFR
Hemocue, Inc.
Chemistry · 141d
Cleared Aug 23, 1996
EQUIPMENT COVERS
K961699 · MMP
United States Surgical, A Division of...
General Hospital · 113d
Cleared Aug 23, 1996
STERITEC DISPOSABLE BIOLOGICAL TEST PACK
K961721 · FRC
Steritec Products Mfg Co, Inc.
General Hospital · 112d
Cleared Aug 23, 1996
ASPECT OPTICAM
K962051 · LMC
Aspect Electronics, Inc.
Radiology · 87d
Cleared Aug 23, 1996
MEDLINE PWDER-FREE VIBNYL EXAMIUNATION GLOVES/VINYL GLOVES, STERILE (MDS...
K962076 · LYY
Medline Industries, Inc.
General Hospital · 87d
Cleared Aug 23, 1996
RPS-50 BEAM SCANNER
K962080 · IYE
Sofield Science Services, Inc.
Radiology · 87d
Cleared Aug 23, 1996
MEDLINE PRE-POWDERED NON-STERILE AND STERILE LATEX EXAMINATION GLOVES
K962094 · LYY
Medline Industries, Inc.
General Hospital · 87d
Cleared Aug 23, 1996
MEDLINE POWDER-FREE NON-STERILE LATEX EXAMINATION GLOVES,MEDLINE POWDER-FREE...
K962095 · LYY
Medline Industries, Inc.
General Hospital · 87d
Cleared Aug 23, 1996
STORZ D4600 AIR EXCHANGE LINE PACK
K962131 · HQC
Storz Instrument Co.
Ophthalmic · 81d
Cleared Aug 23, 1996
NEXGEN KNEE PROSTHESIS & LEGACY KNEE PROSTHESIS W/CO-NIDIUM SURFACE HARDENING...
K962196 · JWH
Zimmer, Inc.
Orthopedic · 78d
Cleared Aug 23, 1996
COMPRESSION SCREW
K962779 · HWC
Orthopaedic Biosystems, Ltd.
Orthopedic · 37d
Cleared Aug 23, 1996
OPUS HLH
K962866 · CEP
Behring Diagnostics, Inc.
Chemistry · 31d
Cleared Aug 23, 1996
ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA
K962875 · CGI
Diagnostic Systems Laboratories, Inc.
Chemistry · 30d
Cleared Aug 23, 1996
SCRIPPS LABORATORIES HCG ONE-STEP
K962906 · JHI
Scripps Laboratories, Inc.
Chemistry · 29d