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
134641–134664 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 07, 1988
MIN ESSENT MED EAGLE FOR SPINN CULTURE, #200-2051
K883628 · KIT
J R Scientific
Pathology · 16d
Cleared Sep 07, 1988
HANK'S BALANCED SALTS (HBSS) CATALOG # 210-3013
K883629 · KIT
J R Scientific
Pathology · 16d
Cleared Sep 07, 1988
RPMI-1640 MEDIUM, CATALOG NO. 210-3525
K883630 · KIT
J R Scientific
Pathology · 16d
Cleared Sep 07, 1988
EX-CELL 300TM, CATALOG # 210-3579
K883631 · KIT
J R Scientific
Pathology · 16d
Cleared Sep 07, 1988
EX-CELL 300TM, CATALOG NO. 210-3575
K883632 · KIT
J R Scientific
Pathology · 16d
Cleared Sep 06, 1988
ZEPHYR
K880534 · FXX
Racal Health & Safety, Inc.
General Hospital · 210d
Cleared Sep 06, 1988
SAM(TM) MODEL ONE
K880725 · BZQ
Sentel Tech. C/O Criticare Systems, Inc.
Anesthesiology · 196d
Cleared Sep 06, 1988
PATIENT VENTILATOR ISOLATOR
K880923 · CBK
Dryden Corp.
Anesthesiology · 186d
Cleared Sep 06, 1988
NUMED BALLOON THERMODILUTION CATHETER
K881893 · KRB
NuMED, Inc.
Cardiovascular · 124d
Cleared Sep 06, 1988
EOL, MODEL LIO
K881984 · HLI
Eol, Inc.
Ophthalmic · 117d
Cleared Sep 06, 1988
PHOTO-CURING LIGHT
K882145 · EBZ
Dentsply Intl.
Dental · 106d
Cleared Sep 06, 1988
BARD BAIM-TURI BALLOON DIAGNOSTIC PACING CATHETER
K882330 · LDF
C.R. Bard, Inc.
Cardiovascular · 92d
Cleared Sep 06, 1988
BOW & ARROW DRILL GUIDE
K882407 · LXI
Instrument Makar, Inc.
Orthopedic · 88d
Cleared Sep 06, 1988
DISPOSABLE ARACHNOID KNIFE
K882422 · HAO
Microbio-Medics, Inc.
Neurology · 85d
Cleared Sep 06, 1988
RK2000 K-THERMIA SYSTEM
K882442 · DWJ
Baxter Healthcare Corp
Cardiovascular · 84d
Cleared Sep 06, 1988
UNDISTAT WITH EXPLORATOR 35 (UCS 35E)
K883153 · IXR
Bay X-Ray, Inc.
Radiology · 42d
Cleared Sep 06, 1988
SELDIX 325 TWO PULSE GENERATOR/CONTROL
K883154 · IZO
Bay X-Ray, Inc.
Radiology · 42d
Cleared Sep 06, 1988
RASTIX X-RAY TABLE
K883155 · KXJ
Bay X-Ray, Inc.
Radiology · 42d
Cleared Sep 06, 1988
TELESTATIX X-RAY TABLE
K883162 · IXR
Bay X-Ray, Inc.
Radiology · 42d
Cleared Sep 06, 1988
MODEL 5866-34A PACEMAKER LEAD ADAPTOR
K883203 · DTB
Medtronic Vascular
Cardiovascular · 40d
Cleared Sep 06, 1988
SURGICAL GOWN/SCRUB/LAPAROTOMY/MAYO STAND/BACK TAB
K883424 · KKX
Intera Corp.
General Hospital · 22d
Cleared Sep 06, 1988
HERAEUS WHITE
K883512 · EJS
Degussa Dental, Inc.
Dental · 20d
Cleared Sep 06, 1988
BIOPORE VS.1 ENDOCARDIAL INTER IMPLANT PACING LEAD
K883602 · DTB
Intermedics, Inc.
Cardiovascular · 14d
Cleared Sep 02, 1988
PHADEBACT ETEC-LT TEST
K874288 · GNA
Pharmacia, Inc.
Microbiology · 318d