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
129865–129888 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 03, 1989
COBAS FARA II CENTRIFUGAL ANALYZER
K893854 · JJG
Roche Diagnostic Systems, Inc.
Chemistry · 70d
Cleared Aug 03, 1989
ABUSCREEN ONTRAK POS. REF. CONTROL FOR BARBITUATES
K893855 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Aug 03, 1989
ABUSCREEN ONTRAK POS. REF. CONTROL FOR MORPHINE
K893856 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Aug 03, 1989
ABUSCREEN ONTRAK POS. REF. CONTROL FOR AMPHETAMINE
K893857 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Aug 03, 1989
ABUSCREEN ONTRAK POS. REFERENCE CONTROL FOR THC
K893858 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Aug 03, 1989
ABUSCREEN ONTRAK POS. REF. CONTROL FOR COCAINE
K893859 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Aug 03, 1989
ABUSCREEN ONTRAK POS.REF.CONTROL FOR PHENCYCLIDINE
K893860 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Aug 03, 1989
GOOTT MULTIPURPOSE FLEXIBLE RETRACTOR (STERILE)
K893869 · GAD
Adept-Med Intl., Inc.
General & Plastic Surgery · 69d
Cleared Aug 03, 1989
GOOTT BALFOUR BLADE
K893871 · GAD
Adept-Med Intl., Inc.
General & Plastic Surgery · 69d
Cleared Aug 03, 1989
PRIMAPORE I.V.
K893900 · KGX
Smith & Nephew United, Inc.
General & Plastic Surgery · 48d
Cleared Aug 03, 1989
PATHODX(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1)
K893905 · LIO
Diagnostic Products Corp.
Microbiology · 65d
Cleared Aug 03, 1989
VENTIPRESS 24 AND 14 PRESSURE VENTILATOR
K893950 · IRP
Ventipress OY
Physical Medicine · 63d
Cleared Aug 03, 1989
ABBOTT IMX(TM) D-DIMER
K893961 · GHH
Abbott Laboratories
Hematology · 63d
Cleared Aug 03, 1989
AMERLEX-MAB FT4 KIT
K894091 · CEC
Amersham Corp.
Chemistry · 55d
Cleared Aug 03, 1989
QUALICHECK 2
K894110 · JJS
Radiometer America, Inc.
Chemistry · 52d
Cleared Aug 03, 1989
OPUS IMMUNOASSAY SYSTEM
K894159 · KHO
Pb Diagnostic Systems, Inc.
Toxicology · 50d
Cleared Aug 03, 1989
ASC-950 ECG AMPLIFIER
K894161 · DRR
Astro-Med, Inc.
Cardiovascular · 50d
Cleared Aug 03, 1989
SENSOCOR TM R-TEST 24OXL
K894234 · DXG
Sensocor
Cardiovascular · 44d
Cleared Aug 03, 1989
UNIVERSAL CEMENTED CUP
K894249 · JDI
Orthopedic Systems, Inc.
Orthopedic · 43d
Cleared Aug 03, 1989
MICRO-AIRE STERNUM SAW 4800
K894301 · KFK
Micro Surgical Instruments Corp.
General & Plastic Surgery · 41d
Cleared Aug 03, 1989
EMIT D.A.U. LOW & MEDIUM CALIBRATOR A
K894327 · DKG
Syva Co.
Toxicology · 20d
Cleared Aug 03, 1989
D88VS WHEELCHAIR POWER SYSTEM
K894346 · ITI
Damaco
Physical Medicine · 20d
Cleared Aug 03, 1989
TUFFCARE MEDICAL PRODUCTS WHEELCHAIR
K894422 · IOR
Tuffman Industries
Physical Medicine · 17d
Cleared Aug 03, 1989
ACS HUMAN PLASMA COAGULATION CONTROL LEVEL III
K894425 · GGC
Analytical Control Systems, Inc.
Hematology · 17d