FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
114313–114336 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 18, 1993
PWB LUMBAR LAMINAR HOOKS WITH SET SCREWS
K924381 · KWP
Cross Medical Products, Inc.
Orthopedic · 260d
Cleared May 18, 1993
BIOMERIEUX HEMOLAB FIBRINOMAT
K925494 · GIS
Biomerieux Vitek, Inc.
Hematology · 197d
Cleared May 18, 1993
STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE
K925661 · KRL
Sorin Biomedica, Fiat, USA, Inc.
Cardiovascular · 189d
Cleared May 18, 1993
TSRH CENTRAL POST HOOKS
K925811 · KWP
Sofamor Danek Mfg., Inc.
Orthopedic · 285d
Cleared May 18, 1993
SOLSTICE XRAY RING MARKER PAD
K925892 · JAC
Solstice Corp.
Radiology · 182d
Cleared May 18, 1993
ORTHOLOC ADVANTIM THICK TIBIAL BASE COMPONENT
K926257 · JWH
Dow Corning Wright
Orthopedic · 151d
Cleared May 18, 1993
BBL CRYSTAL MRSA ID SYSTEM
K926294 · JWY
Becton Dickinson Microbiology Systems
Microbiology · 155d
Cleared May 18, 1993
CAPTUS 2000 WEL COUNTER
K930962 · IZD
Capintec Instruments, Inc.
Radiology · 83d
Cleared May 18, 1993
LIFEPAK 10 DEFIBRILLATOR/MONITOR W/OPT PACEMAKER
K931053 · LDD
Physio-Control Corp.
Cardiovascular · 71d
Cleared May 18, 1993
BLUE LINE(R) PDT(TM) PORTEX DIRECTIONAL TUBE
K931735 · BTR
Smiths Industries Medical Systems, Inc.
Anesthesiology · 41d
Cleared May 17, 1993
PPC HIP STEM COMPONENT
K915385 · JDG
Implantology Corp.
Orthopedic · 535d
Cleared May 17, 1993
TOP-X 650HF RADIOGRAPHIC X-RAY
K920347 · KPR
Control-X, Inc.
Radiology · 479d
Cleared May 17, 1993
INTRAVENOUS CATHETERS MODIFICATIONS
K921295 · FGO
Critikon Company, LLC
Gastroenterology & Urology · 431d
Cleared May 17, 1993
ELECTROSURGICAL UNITS ESU 100L, 100 L M/M & E M/M
K921770 · GEI
Elmed, Inc.
General & Plastic Surgery · 399d
Cleared May 17, 1993
K-STIM CLEAR
K922202 · GZJ
Katecho, Inc.
Neurology · 371d
Cleared May 17, 1993
ANTEGRADE/RETROGRADE CARDIOPLEGIA VALVE SYSTEMS
K922840 · DTL
Gish Biomedical, Inc.
Cardiovascular · 339d
Cleared May 17, 1993
OPTILITE FIBEROPTIC DELIVERY SYSTEMS
K923599 · GEX
Xintec Corporation
General & Plastic Surgery · 301d
Cleared May 17, 1993
# 9455 AND #9457 POOLE TIP SUCTION PROBE
K923908 · GCY
O.R. Concepts, Inc.
General & Plastic Surgery · 286d
Cleared May 17, 1993
PROWESS 2000
K924240 · IYE
Small Systems Group, Inc.
Radiology · 266d
Cleared May 17, 1993
SOFT-MIST(TM)
K924649 · CAF
Vortran Medical Technology 1, Inc.
Anesthesiology · 244d
Cleared May 17, 1993
UNIVERSAL SURGICAL INSTRUMENT HOLDER
K924713 · FWW
T. Korossurgical Instruments Corp.
General & Plastic Surgery · 241d
Cleared May 17, 1993
THE BODYGUARDS ULTRA POW-FREE HYPO LATEX EXAM GLOV
K924909 · LYY
T.K. Glove Products Co., Ltd.
General Hospital · 230d
Cleared May 17, 1993
INSTRUMENTARIUM MEGA4 HT
K924921 · LNH
Instrumentarium Imaging, Inc.
Radiology · 234d
Cleared May 17, 1993
NEEDLE, PNEUMOPERITONEUM, SPRING LOADED
K924931 · GCJ
Lpc, Inc.
General & Plastic Surgery · 229d