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
134593–134616 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 09, 1988
PREGNAGEN(TM)
K882002 · JHI
Biogenex Laboratories
Chemistry · 119d
Cleared Sep 09, 1988
MINIM-X 2001-CIAS & MINIM-X 2002-CIAS
K882379 · EAP
Dentomar, Inc.
Radiology · 92d
Cleared Sep 09, 1988
OPHTHALMIC FLUID INJECTOR
K882403 · FMF
Trek Medical Products, Inc.
General Hospital · 91d
Cleared Sep 09, 1988
MODIFIED AMERICAN LUBRICATING JELLY, 2.7 & 5.0
K882506 · KMJ
Span-America Medical Systems, Inc.
General Hospital · 92d
Cleared Sep 09, 1988
OPHTHALMIC PAO VALVE
K882536 · FMF
Look, Inc.
General Hospital · 80d
Cleared Sep 09, 1988
GESCO CATHETERIZATION TRAY
K882647 · GBQ
Gesco Intl., Inc.
General & Plastic Surgery · 74d
Cleared Sep 09, 1988
KTP/YAG(TM) SURGICAL LASER
K882734 · GEX
Laserscope
General & Plastic Surgery · 70d
Cleared Sep 09, 1988
MODEL AU-1 ACCESSORY UNIT
K882926 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 58d
Cleared Sep 09, 1988
STAT FAX(TM)
K882938 · JJQ
Awareness Technology, Inc.
Chemistry · 58d
Cleared Sep 09, 1988
BLOOD GAS MIXTURE
K882941 · CHL
Swisco, Inc.
Chemistry · 64d
Cleared Sep 09, 1988
A.QC CHEMISTRY CONTROL LEVEL 2
K883012 · JJY
Arden Medical Systems, Inc.
Chemistry · 52d
Cleared Sep 09, 1988
T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS
K883085 · KHQ
Serono Diagnostics, Inc.
Chemistry · 49d
Cleared Sep 09, 1988
DADE TDM CONTROL
K883190 · DIF
Baxter Healthcare Corp
Pathology · 43d
Cleared Sep 09, 1988
ALTLTS ALANINE AMINO TRANSFERASE ALT
K883205 · CKA
Electro-Nucleonics, Inc.
Chemistry · 43d
Cleared Sep 09, 1988
LACTATE DEHYDROGENASE LDH
K883206 · CFJ
Electro-Nucleonics, Inc.
Chemistry · 43d
Cleared Sep 09, 1988
PHASE II FSH KIT
K883279 · CGJ
Vitek Systems, Inc.
Chemistry · 37d
Cleared Sep 09, 1988
DOUBLE ANTIBODY BENZODIAZPINES #KBZD1, KBZD5
K883459 · JXM
Diagnostic Products Corp.
Toxicology · 28d
Cleared Sep 08, 1988
MYOCARD BIOPSY FORCEP
K881412 · DWZ
Fehling Medizintechnik GmbH
Cardiovascular · 157d
Cleared Sep 08, 1988
VAC-G (GUILLOTINE VITRECTOR)
K881519 · HQE
B&B Medical Assoc., Inc.
Ophthalmic · 150d
Cleared Sep 08, 1988
RADKOR SFC-21
K881701 · IYB
Radkor, Inc.
Radiology · 142d
Cleared Sep 08, 1988
TRANSCRAN(TM) TRANSCRANIAL PULSED DOPPLER SYSTEM
K882015 · IYN
Ultramed, Inc.
Radiology · 118d
Cleared Sep 08, 1988
OLYMPUS REPLY CHEMISTRY ANALYZER
K882451 · JJE
Olympus Corp.
Chemistry · 86d
Cleared Sep 08, 1988
ADDIT. DATA FOR BREAKPOINT/ID GRAM-NEG. PANEL
K882477 · JWY
Pasco Laboratories, Inc.
Microbiology · 86d
Cleared Sep 08, 1988
METATECH ROBINSON BOLT ACCESSORY
K882552 · GWM
Metatech Corp.
Neurology · 79d