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
98041–98064 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 24, 1996
SYNERGIST POWER PACK
K960414 · HQC
Chiron Vision Corp.
Ophthalmic · 86d
Cleared Apr 24, 1996
D & K SUNGLASSES
K960798 · HQY
D&K Stores, Inc.
Ophthalmic · 57d
Cleared Apr 24, 1996
SUNGLASSES
K961034 · HQY
Kylie Enterprise Co. , Ltd.
Ophthalmic · 44d
Cleared Apr 24, 1996
VISARD SUNGLASSES
K961117 · HQY
Visard Srl
Ophthalmic · 35d
Cleared Apr 24, 1996
SUNGLASSES
K961128 · HQY
Vision-Pro Industrial, Ltd.
Ophthalmic · 34d
Cleared Apr 24, 1996
OAKLEY, INC SUNGLASSES
K961268 · HQY
Oakley, Inc.
Ophthalmic · 22d
Cleared Apr 23, 1996
ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION
K940176 · MFD
Ackrad Laboratories
Obstetrics & Gynecology · 833d
Cleared Apr 23, 1996
ECLIPSE 4 ELECTROCARDIOGRAPH
K946281 · LOS
Burdick, Inc.
Cardiovascular · 483d
Cleared Apr 23, 1996
ACKRAD ESOPHAGEAL BALLOON CATHETER SET
K952542 · BZC
Ackrad Laboratories
Anesthesiology · 336d
Cleared Apr 23, 1996
QUESTLOCK ACL FIXATOR
K954683 · MBI
Wrightmedicaltechnologyinc
Orthopedic · 195d
Cleared Apr 23, 1996
PROTECTOR RETRACTOR & PROTECTOR RETRACTOR WITH DRAPE
K954824 · KKX
Medical Creative Technologies, Inc.
General Hospital · 186d
Cleared Apr 23, 1996
FREE FLOW SAFETY DEVICE
K954883 · FPA
Migada, Inc.
General Hospital · 186d
Cleared Apr 23, 1996
RIT LIVER, KIDNEY, STOMACH IFA KIT
K955431 · DBL
The Binding Site, Ltd.
Immunology · 147d
Cleared Apr 23, 1996
SYNTHAFAX APTT REAGENT
K955638 · GFO
Ortho Diagnostic Systems, Inc.
Hematology · 134d
Cleared Apr 23, 1996
MINICLINIC OVULATION PREDICTOR
K960233 · CEP
Vanguard Biomedical Corp.
Chemistry · 97d
Cleared Apr 23, 1996
LIQUID CARDIAC MARKER 1,2,3 ASSAYED
K960246 · JJT
Ciba Corning Diagnostics Corp.
Chemistry · 98d
Cleared Apr 23, 1996
STEREOTACTIC BODY FRAME
K960338 · IYE
Elekta Instrument AB
Radiology · 90d
Cleared Apr 23, 1996
APOLLO TOTAL KNEE SYSTEM SINGLE LUG PATELLA
K960535 · JWH
Intermedics Orthopedics
Orthopedic · 76d
Cleared Apr 23, 1996
CYNOSURE PHOTOGENICA VL CUTANEOUS VASCULAR LESION LASER
K960579 · GEX
Cynosure, Inc.
General & Plastic Surgery · 71d
Cleared Apr 23, 1996
EXACTECH STERILE MODULAR DRILL BIT
K960720 · HWE
Exactech, Inc.
Orthopedic · 61d
Cleared Apr 23, 1996
IMMUNOLOGY CONTROL
K960824 · JJY
Medical Analysis Systems, Inc.
Chemistry · 54d
Cleared Apr 23, 1996
PULPDENT ENDOPREP II
K961089 · EKL
Pulpdent Corp.
Dental · 35d
Cleared Apr 23, 1996
LARES RESEARCH AS-1 LOWSPEED HANDPIECE
K961163 · EFB
Lares Research, Inc.
Dental · 32d
Cleared Apr 23, 1996
DSL ACTIVE NON-EXTRACTION IGF-I IRMA
K961172 · CFL
Diagnostic Systems Laboratories, Inc.
Chemistry · 29d