FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
84385–84408 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 22, 1999
SUTURE CLINCH
K992852 · GCJ
Applied Medical Resources
General & Plastic Surgery · 90d
Cleared Nov 22, 1999
STAK-CHEX PLUS RETICS
K992887 · GLQ
Streck Laboratories, Inc.
Hematology · 87d
Cleared Nov 22, 1999
FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000
K993046 · FEO
Fibra Sonics, Inc.
Gastroenterology & Urology · 73d
Cleared Nov 22, 1999
3D1 MICROPOSITIONING HEADSTAGE
K993501 · HAW
Scientific Tools, Inc.
Neurology · 38d
Cleared Nov 22, 1999
ENDOSPINE OPERATING TUBE AND TELESCOPE BRIDGE
K993540 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 34d
Cleared Nov 22, 1999
DISETRONIC PEN P100
K993666 · FMF
Disetronic Medical Systems
General Hospital · 21d
Cleared Nov 19, 1999
I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR...
K990292 · HQE
Ophthalmic Consultants, Inc.
Ophthalmic · 294d
Cleared Nov 19, 1999
OSTEO-PIN MEMBRANE FIXATION PIN
K990537 · LYC
Luitpold Pharmaceuticals, Inc.
Dental · 273d
Cleared Nov 19, 1999
SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS
K992832 · DSY
Sulzermedica
Cardiovascular · 88d
Cleared Nov 19, 1999
ALARMVIEW SYSTEM
K992848 · MSX
Data Critical Corp.
Cardiovascular · 87d
Cleared Nov 19, 1999
HI BOND NON-PRECIOUS CERAMIC ALLOY
K992881 · EJH
Matech, Inc.
Dental · 85d
Cleared Nov 19, 1999
VERSALOK LOW BACK FIXATION SYSTEM
K992885 · KWP
Osteotech, Inc.
Orthopedic · 84d
Cleared Nov 19, 1999
OXY-GLIDE ROOT CANAL CLEANSER & LUB.
K992919 · KJJ
Super Glide, Inc.
Dental · 81d
Cleared Nov 19, 1999
LORENZ DISTRACTION SYSTEM
K992952 · MQN
Walter Lorenz Surgical, Inc.
Dental · 79d
Cleared Nov 19, 1999
IBC VENT VALVE, MODEL 1400
K992964 · MNJ
International Biophysics Corp.
Cardiovascular · 78d
Cleared Nov 19, 1999
DISPOSABLE PVC POWDERED SYNTHETIC EXAMINATION GLOVES
K993049 · LYZ
Shanghai Antares Industries, Inc.
General Hospital · 70d
Cleared Nov 19, 1999
STRYKER LEIBINGER RESORBABLE FIXATION SYSTEM
K993061 · MAI
Stryker Instruments
Orthopedic · 67d
Cleared Nov 19, 1999
EXACTECH ACUMATCH INTEGRATED HIP SYSTEM A-SERIES POROUS COATED ACETABULAR...
K993082 · LPH
Exactech, Inc.
Orthopedic · 65d
Cleared Nov 19, 1999
POWDER FREE GLOVES (POLYMER COATED)
K993183 · LYY
Pan-Century Rubber Products Sdn. Bhd.
General Hospital · 57d
Cleared Nov 19, 1999
COMFIT POWDER FREE NITRILE EXAMINATION GLOVE, STERILE
K993311 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 46d
Cleared Nov 19, 1999
NIL, NITRILE EXAMINATION GLOVE - POWDERED
K993347 · LZA
Sri Anusham Rubber Industries Pvt., Ltd.
General Hospital · 45d
Cleared Nov 19, 1999
NIL, NITRILE EXAMINATION GLOVE - POWDER FREE
K993348 · LZA
Sri Anusham Rubber Industries Pvt., Ltd.
General Hospital · 45d
Cleared Nov 19, 1999
CROSSFIRE SYSTEM 12 ACETABULAR INSERTS
K993352 · LPH
Howmedica Osteonics Corp.
Orthopedic · 45d
Cleared Nov 19, 1999
OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE
K993419 · LYY
Omnigrace , Ltd.
General Hospital · 38d