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
94009–94032 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 12, 1997
SPECTRUM DESIGNS SPECTRAGEL
K970702 · MDA
Spectrum Designs, Inc.
General & Plastic Surgery · 75d
Cleared May 12, 1997
GREINER VACUETTE BLOOD COLLECTION TUBE
K971236 · JKA
Greiner America, Inc.
Toxicology · 40d
Cleared May 12, 1997
GREINER VACUETTE BLOOD COLLECTION TUBE
K971239 · JKA
Greiner America, Inc.
Chemistry · 40d
Cleared May 12, 1997
DSL ACTIVE NON-EXTRACTION IGF-I ELISA
K971353 · CFL
Diagnostic Systems Laboratories, Inc.
Chemistry · 31d
Cleared May 09, 1997
WS FREQUENCY SPECTRUM EFFECT PHYSIATRICS APPARATUS
K954577 · ILY
C.A.I. Industries Corp.
Physical Medicine · 585d
Cleared May 09, 1997
SYNTHES (U.S.A.) POLYPIN
K961608 · HTY
Synthes (Usa)
Orthopedic · 379d
Cleared May 09, 1997
TOMEY DTL ELECTRODE
K961805 · HLZ
Tomey Corporation USA
Ophthalmic · 364d
Cleared May 09, 1997
NEUROMATE STEREOTACTIC SYSTEM
K963256 · HAW
Integrated Surgical Systems, S.A.
Neurology · 263d
Cleared May 09, 1997
COMBINATION OXIMETER/CARBON DIOXIDE GAS ANALYZER
K964239 · CCK
Spegas Industries, Ltd.
Anesthesiology · 198d
Cleared May 09, 1997
HEARTPORT THORACIC TROCAR
K964302 · DRC
Heartport, Inc.
Cardiovascular · 192d
Cleared May 09, 1997
AD-TECH'S DEPTH ELECTRODE
K964644 · GZL
Ad-Tech Medical Instrument Corp
Neurology · 190d
Cleared May 09, 1997
BLEDSOE COLD CONTROL
K964710 · ILO
Med Technology, Inc.
Physical Medicine · 165d
Cleared May 09, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT
K964781 · DDS
Beckman Instruments, Inc.
Immunology · 163d
Cleared May 09, 1997
WINMAX SOFTWARE SYSTEMS
K965103 · JJF
Diagnostic Products Corp.
Chemistry · 140d
Cleared May 09, 1997
VALUETRODE
K970426 · GXY
Axelgaard Mfg. Co., Ltd.
Neurology · 94d
Cleared May 09, 1997
K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH
K970441 · FPX
Medi-Flex Hospital Products, Inc.
General & Plastic Surgery · 93d
Cleared May 09, 1997
HANNIBAL GUIDEWIRE
K970494 · DQX
Schneider (Europe) GmbH
Cardiovascular · 88d
Cleared May 09, 1997
HEARTPORT MAZE SYSTEM: CRYOPROBE SET
K970496 · OCL
Heartport, Inc.
Cardiovascular · 88d
Cleared May 09, 1997
SULLIVAN AUTOSET HOME NASAL CPAP SYSTEM
K970516 · BZD
Resmed, Ltd.
Anesthesiology · 87d
Cleared May 09, 1997
AD-TECH SUBDURAL ELECTRODE
K970587 · GYC
Ad-Tech Medical Instrument Corp
Neurology · 80d
Cleared May 09, 1997
STAT PROFILE ULTRA M ANALYZER
K970710 · CHL
Nova Biomedical Corp.
Chemistry · 72d
Cleared May 09, 1997
OPTI-PLAST XL 5.5 F PTA CATHETER
K970725 · LIT
Vas-Cath, Inc.
Cardiovascular · 70d
Cleared May 09, 1997
SEE3 (LOTRAFILCON A) SOFT CONTACT LENS
K970746 · LPL
Ciba Vision Corporation
Ophthalmic · 70d
Cleared May 09, 1997
TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEM
K970748 · KTT
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 67d