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
87433–87456 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 13, 1999
CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15...
K981174 · GJT
Precision Biologicals, Inc.
Hematology · 287d
Cleared Jan 13, 1999
CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10
K982062 · GGW
Precision Biologicals, Inc.
Hematology · 212d
Cleared Jan 13, 1999
LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY
K982115 · LYL
Rim-Wide Companies, Inc.
Ophthalmic · 211d
Cleared Jan 13, 1999
HEART-LIFT BALLOON POSITIONER
K982419 · MWS
Cardiothoracic Systems, Inc.
Cardiovascular · 184d
Cleared Jan 13, 1999
SERAQUEST CMV IGM
K982485 · LFZ
Quest Intl., Inc.
Microbiology · 180d
Cleared Jan 13, 1999
SNN SCOUT
K982570 · HAW
I.S.G. Technologies, Inc.
Neurology · 174d
Cleared Jan 13, 1999
SENSIFLEX POWDERFREE SURGEON'S GLOVE
K982957 · KGO
Terang Nusa Sdn Bhd
General Hospital · 142d
Cleared Jan 13, 1999
VYGON DOUBLE LUMEN PICC-CATHETERS (4FR. AND 5FR.)
K983544 · LJS
Vygon Corp.
General Hospital · 96d
Cleared Jan 13, 1999
MB/BACT BLOOD CULTURE BOTTLE
K983772 · MDB
Organon Teknika Corp.
Microbiology · 79d
Cleared Jan 13, 1999
NETILMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K984036 · JTN
Oxoid , Ltd.
Microbiology · 62d
Cleared Jan 13, 1999
BLOSSOM POWDERED LATEX EXAMINATION GLOVES
K984040 · LYY
Mexpo Intl., Inc.
General Hospital · 62d
Cleared Jan 13, 1999
OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABELING CLAIM
K984066 · KGO
Omni Intl., Inc.
General Hospital · 58d
Cleared Jan 13, 1999
STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK
K984067 · JHX
Dade Behring, Inc.
Chemistry · 58d
Cleared Jan 13, 1999
MAINBOND A
K984140 · EJT
J.F. Jelenko & Co., Inc.
Dental · 56d
Cleared Jan 13, 1999
WAKO L-TYPE AMYLASE
K984184 · JFJ
Wako Chemicals USA, Inc.
Chemistry · 51d
Cleared Jan 13, 1999
ORAL-EZE ORAL FLUID COLLECTION SYSTEM
K984361 · PJD
Osborn Laboratories, Inc.
Chemistry · 37d
Cleared Jan 13, 1999
R-30 AESTHETIC RESTORATIVE
K984387 · EBF
Dentsply Intl.
Dental · 36d
Cleared Jan 13, 1999
MICROSTAT 2
K984485 · LRJ
Chemlink Laboratories, LLC
General Hospital · 27d
Cleared Jan 13, 1999
CARESIDE ALKALINE PHOSPHATASE
K990024 · CJE
Careside, Inc.
Chemistry · 8d
Cleared Jan 12, 1999
GOLDMAN MANUAL TONOMETER
K981432 · HKY
Golden Vision, Inc.
Ophthalmic · 267d
Cleared Jan 12, 1999
POSI-STOP/POSI-TRAC SYSTEM
K981997 · DZE
The Dental Medical Device Co., LLC
Dental · 218d
Cleared Jan 12, 1999
ABBOTT PLUM A+ INFUSION PUMP
K982159 · FRN
Abbott Laboratories
General Hospital · 207d
Cleared Jan 12, 1999
CYBER-LASE 2000 CURING AND WHITENING LASER
K983654 · GEX
Ics of North America, Inc.
General & Plastic Surgery · 85d
Cleared Jan 12, 1999
BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES
K983661 · EIA
Belmont Equipment Corp.
Dental · 85d