FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
89857–89880 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 27, 1998
TRIANGLE SLING
K980482 · OTN
Influence, Inc.
Gastroenterology & Urology · 46d
Cleared Mar 27, 1998
FOTONA SKINPLUS LASER SYSTEM
K980560 · GEX
Fotona D.D.
General & Plastic Surgery · 42d
Cleared Mar 27, 1998
PARA-CARE
K980718 · IMC
Chattanooga Group, Inc.
Physical Medicine · 31d
Cleared Mar 27, 1998
3 MM SELEC-TIP LAPAROSCOPIC SCISSORS
K980758 · GEI
Microline Pentax, Inc.
General & Plastic Surgery · 28d
Cleared Mar 27, 1998
WINDMERE MODEL DS-2 FOOT BATH
K980769 · ILJ
Windmere Corp.
Physical Medicine · 28d
Cleared Mar 26, 1998
TECA NCS ELECTRODE SYSTEM 2000
K971914 · GXY
Medelec, Inc. D.B.A. Teca Corp.
Neurology · 307d
Cleared Mar 26, 1998
EA-D IGG ELISA TEST SYSTEM
K973123 · LSE
Clark Laboratories, Inc.
Microbiology · 218d
Cleared Mar 26, 1998
N-ASSAY CPK-L
K980900 · CGS
Crestat Diagnostics, Inc.
Chemistry · 16d
Cleared Mar 26, 1998
N-ASSAY L AST/GOT
K980902 · CIT
Crestat Diagnostics, Inc.
Chemistry · 16d
Cleared Mar 25, 1998
CROSS-CHECKS P
K972300 · JOJ
Steritec Products Mfg Co, Inc.
General Hospital · 279d
Cleared Mar 25, 1998
DMR PLUS DISPOSABLE MANUAL RESUSCITATOR
K973419 · BTM
Nellcor Puritan Bennett, Inc.
Anesthesiology · 196d
Cleared Mar 25, 1998
ELECSYS CA 125II ON THE ELECSYS 1010
K980240 · LTK
Boehringer Mannheim Corp.
Immunology · 61d
Cleared Mar 25, 1998
MEDI-GRIP (BEIGE 43)SURGICAL GLOVES
K980564 · KGO
Ansell Perry
General Hospital · 40d
Cleared Mar 25, 1998
BCI 3401 HANDHELD PULSE OXIMETER
K980714 · DQA
Bci Intl., Inc.
Anesthesiology · 29d
Cleared Mar 25, 1998
NITRILE EXAM GLOVE, POWDER-FREE, BLUE
K980802 · LZA
Tucker & Associates
General Hospital · 23d
Cleared Mar 25, 1998
AFFINITY MEDICAL PATIENT CABLE SYSTEM
K980806 · DSA
Affinity Medical Technologies, LLC
Cardiovascular · 22d
Cleared Mar 24, 1998
ASTRA TECH IMPLANT DENTAL SYSTEM
K974737 · DZE
Astra Tech, Inc.
Dental · 95d
Cleared Mar 24, 1998
BRANEMARK SYSTEM(R) EBON(TM) FIXTURE
K974828 · DZE
Nobel Biocare Uas, Inc.
Dental · 90d
Cleared Mar 24, 1998
ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM
K974906 · KLE
Coltene/Whaledent, Inc.
Dental · 83d
Cleared Mar 24, 1998
3600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 3000
K980089 · FRN
Valley West, Inc.
General Hospital · 74d
Cleared Mar 24, 1998
ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM)
K980090 · LJS
Luther Medical Products, Inc.
General Hospital · 74d
Cleared Mar 24, 1998
QUANTA LITE B2 GPI SCREEN
K980230 · MSV
Inova Diagnostics, Inc.
Immunology · 61d
Cleared Mar 24, 1998
IP-16
K980301 · BTA
Servizi Medico Estetici Italinai Srl.
General & Plastic Surgery · 56d
Cleared Mar 24, 1998
AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR...
K980574 · JLW
Alfa Biotech (Uk) , Ltd.
Chemistry · 35d