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
89185–89208 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 02, 1998
3ML STERI-NEB SALINE - 0.9% W/V SODIUM CHLORIDE INHALATION SOLUTION USP
K980829 · CAF
Steripak, Ltd.
Anesthesiology · 90d
Cleared Jun 02, 1998
REUSABLE MEGABEAM FIBER OPTIC DELIVERY SYSTEM
K980838 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 90d
Cleared Jun 02, 1998
EXETER INTRAMEDULLARY BONE PLUG
K980843 · JDI
Howmedica, Inc.
Orthopedic · 90d
Cleared Jun 02, 1998
ZEUS SCIENTIFIC, INC. ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM
K981014 · MID
Zeus Scientific, Inc.
Immunology · 76d
Cleared Jun 02, 1998
ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEM
K981021 · MID
Zeus Scientific, Inc.
Immunology · 75d
Cleared Jun 01, 1998
EAGLE CENTURY STEAM STERILIZER
K964332 · FLE
Amsco Intl., Inc.
General Hospital · 579d
Cleared Jun 01, 1998
LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB0400G)
K971006 · LSR
Mrl Diagnostics
Microbiology · 439d
Cleared Jun 01, 1998
LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M)
K971007 · LSR
Mrl Diagnostics
Microbiology · 439d
Cleared Jun 01, 1998
FOCUS RTP SYSTEM
K973936 · IYE
Computerized Medical Systems, Inc.
Radiology · 229d
Cleared Jun 01, 1998
ICON IMPLANT SYSTEM
K974106 · DZE
Bio Science Technologies, Inc.
Dental · 213d
Cleared Jun 01, 1998
COBE(R) CML DUO(R) WITH SMART(TM) SURFACE MODIFIED MEMBRANCE OXYGENATOR
K974812 · DTZ
Cobe Cardiovascular, Inc.
Cardiovascular · 160d
Cleared Jun 01, 1998
STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK
K980100 · MSR
Storz Instrument Co.
Ophthalmic · 140d
Cleared Jun 01, 1998
EQUIDOSE SOLID STATE DIODE DETECTORS
K980826 · IYE
Cii Mastek, Inc.
Radiology · 90d
Cleared Jun 01, 1998
SNORE-CURE ANTI-SNORING APPLIANCE
K980952 · LRK
Ortho-Tain, Inc.
Dental · 80d
Cleared Jun 01, 1998
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES
K981062 · LYY
Ideal Quality Sdn., Bhd.
General Hospital · 70d
Cleared Jun 01, 1998
ETEST CEFTRIAXONE
K981139 · JWY
Ab Biodisk
Microbiology · 63d
Cleared Jun 01, 1998
PROFLEX POWDER FREE NITRILE EXAMINATION GLOVES
K981159 · LZA
Latexx Partners Bhd.
General Hospital · 62d
Cleared Jun 01, 1998
ULTIMAX DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM
K981230 · HSB
Biodynamic Technologies, Inc.
Orthopedic · 59d
Cleared Jun 01, 1998
MIRACLE MIX CAPSULE
K981370 · EMA
GC America, Inc.
Dental · 47d
Cleared Jun 01, 1998
ANATOMARK NONINVASIVE HEAD REFERENCE SYSTEM
K981398 · LNH
Interneuron Pharmaceuticals, Inc.
Radiology · 45d
Cleared Jun 01, 1998
DIASCREEN REAGENT STRIPS
K981555 · LJX
Chronimed, Inc.
Chemistry · 31d
Cleared May 29, 1998
B-D AUTO-INJECTOR
K974678 · KZH
Bd Becton Dickinson Vacutainer...
General Hospital · 165d
Cleared May 29, 1998
STRYKER SE5 ARTHROSCOPY SYSTEM WITH HERMES VOICE CONTROL
K974771 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 158d
Cleared May 29, 1998
ETEST CHLORAMPHENICAL
K980342 · JWY
Ab Biodisk
Microbiology · 121d