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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
145585–145608 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 07, 1986
ISOTRAK AMYLASE TEST AMYLASE ISOENZYME
K853951 · CIJ
Behring Diagnostics, Inc.
Chemistry · 104d
Cleared Jan 07, 1986
CD-100 CARDIAC MONITOR
K854041 · DRT
Cardio Display Corp.
Cardiovascular · 97d
Cleared Jan 07, 1986
PROGRAMALITH III MODELS 238 & 239
K854195 · DXY
Pacesetter Systems
Cardiovascular · 84d
Cleared Jan 07, 1986
MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT
K854379 · JLW
Bioclinical Systems, Inc.
Chemistry · 69d
Cleared Jan 07, 1986
MICROSAMPLE COAGULATION ANALYSER MODEL 110P
K854546 · JPA
Bio/Data Corp.
Hematology · 55d
Cleared Jan 07, 1986
NSI ASTRA TM CALCIUM REAGENT KIT NSI ITEM # 7909
K854716 · CIC
Nobel Scientific Industries, Inc.
Chemistry · 46d
Cleared Jan 07, 1986
LEE-BEAD BETA LH (EIA)
K854838 · CEP
Leeco Diagnostics, Inc.
Chemistry · 35d
Cleared Jan 07, 1986
CRITIC - SF, ASSAYED
K854967 · JJY
Dimension Diagnostics
Chemistry · 27d
Cleared Jan 07, 1986
CLEARENE, CLEARING AGENT
K855109 · KEM
Surgipath Medical Industries, Inc.
Pathology · 15d
Cleared Jan 07, 1986
DRI-FORM UREAPLASMA DIFFERENTIAL BASAL AGAR MED.A8
K855110 · JSI
Gibco Laboratories Life Technologies,...
Microbiology · 15d
Cleared Jan 06, 1986
GOODE T-TUBE WHITE SILICONE TYMPANOSTOMY TUBE
K852387 · ETD
Xomed, Inc.
Ear, Nose, Throat · 215d
Cleared Jan 06, 1986
ADR 3160 W/PROBES PLB-308M, PLB-508M, & PLB-310M
K852947 · ITX
Advanced Technology Laboratories, Inc.
Radiology · 179d
Cleared Jan 06, 1986
GODDE T-TUBE BLUE SILICONE TYMPANOSTOMY TUBE
K853641 · ETD
Xomed, Inc.
Ear, Nose, Throat · 125d
Cleared Jan 06, 1986
DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENT
K854089 · JPA
Diatech, Inc.
Hematology · 91d
Cleared Jan 06, 1986
DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENT
K854090 · JPA
Diatech, Inc.
Hematology · 91d
Cleared Jan 06, 1986
TUBING SYRING
K854699 · ECB
Almore Intl., Inc.
Dental · 46d
Cleared Jan 03, 1986
AKUFON THERAPEUTIC MASSAGER
K850495 · IRO
Jansson A/S
Physical Medicine · 329d
Cleared Jan 03, 1986
VITATRON M
K852034
Elmed, Inc.
Physical Medicine · 239d
Cleared Jan 03, 1986
SATALEC SEPTOSONIC SC 80/SC 120
K852527 · FLG
Spelna, Inc.
General Hospital · 203d
Cleared Jan 03, 1986
GAS/PRES MONIT ENDOT TUB CONN/ADOP W/ & W/O TUB
K852632 · CAI
Medicomp, Inc.
Anesthesiology · 197d
Cleared Jan 03, 1986
THERACUSHION
K853710 · ISA
General Physiotherapy, Inc.
Physical Medicine · 120d
Cleared Jan 03, 1986
MEDAR APM FORCE TRANSDUCER
K853849 · BXN
Medar Corp., Inc.
Anesthesiology · 109d
Cleared Jan 03, 1986
ASSERA PLATE IX:AG KIT
K854014 · GGP
American Bioproducts Co.
Hematology · 98d
Cleared Jan 03, 1986
ASSERACHROM PROTEIN C KIT
K854016 · JLA
American Bioproducts Co.
Hematology · 98d