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
145393–145416 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 22, 1986
MODEL TRC-40 TELEMETRY RECIEVER MODULE
K851623 · DXH
Eaton Medical Group
Cardiovascular · 279d
Cleared Jan 22, 1986
INTRA-AORTIC BALLOON PUMP MODEL K2000
K853062 · DSP
Kontron Instruments, Inc.
Cardiovascular · 187d
Cleared Jan 22, 1986
CMS 8000
K853096 · DXH
Physio-Control Corp.
Cardiovascular · 183d
Cleared Jan 22, 1986
NARKOMED 3 ANESTHESIA SYSTEM
K853435 · BSZ
Draeger Medical, Inc.
Anesthesiology · 160d
Cleared Jan 22, 1986
IOSERT LENS IMPLANT INSTRUMENT
K854197 · KYB
Chiron Vision Corp.
Ophthalmic · 99d
Cleared Jan 22, 1986
SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV
K854245 · KQN
Sigma Diagnostics, Inc.
Chemistry · 93d
Cleared Jan 22, 1986
DSL ANDROSTENEDIONE RIA (DSL # 4200)
K854673 · CIZ
Diagnostic Systems Laboratories, Inc.
Chemistry · 62d
Cleared Jan 22, 1986
TRIGLYCERIDE'S TEST (TRIGLI-CINET)
K854783 · CDT
Sclavo, Inc.
Chemistry · 54d
Cleared Jan 22, 1986
V-TREND DIG ENZYME IMMUNOASSAY TEST KIT
K854972 · KXT
V-Tech, Inc.
Chemistry · 42d
Cleared Jan 22, 1986
SERALYZER TOTAL BILIRUBIN CALIBRATORS
K855040 · JIS
Miles Laboratories, Inc.
Chemistry · 36d
Cleared Jan 22, 1986
CALCIUM LIQUID STABLE REAGENT SET
K855041 · CIC
Medical Analysis Systems, Inc.
Chemistry · 36d
Cleared Jan 22, 1986
EMDS TOTAL CK TEST PACK-#67670/95
K855056 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Jan 22, 1986
TELEMETRY WAND MODEL
K855171 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 27d
Cleared Jan 22, 1986
GLUCOSE REAGENT SET
K855185 · CGE
Technostics Intl.
Chemistry · 27d
Cleared Jan 22, 1986
CLEANING REAGENT KIT PRODUCT NO 88194
K855196 · JJE
Hi Chem, Inc.
Chemistry · 27d
Cleared Jan 22, 1986
DETERMINATION OF GENTAMICIN
K860045 · LCD
Clinical Data, Inc.
Toxicology · 16d
Cleared Jan 22, 1986
DETERMINATION OF PHENOBARBITAL
K860046 · DLZ
Clinical Data, Inc.
Toxicology · 16d
Cleared Jan 22, 1986
DETERMINATION OF CARBAMAZEPINE
K860047 · KLT
Clinical Data, Inc.
Toxicology · 16d
Cleared Jan 22, 1986
DETERMINATION OF PHENYTOIN (DIPHENYLHYDANTOIN)
K860048 · DIP
Clinical Data, Inc.
Toxicology · 16d
Cleared Jan 22, 1986
DETERMINATION OF QUINIDINE
K860049 · LBZ
Clinical Data, Inc.
Toxicology · 16d
Cleared Jan 21, 1986
ROKONICS SENTRY MODEL 8500
K851819 · BZQ
Rokonics, Inc.
Anesthesiology · 270d
Cleared Jan 21, 1986
HSV2 - IGG ELISA-KIT
K852781 · GQO
Clinical Sciences, Inc.
Microbiology · 204d
Cleared Jan 21, 1986
HSVI - IGG ELISA-KIT
K852782 · GQO
Clinical Sciences, Inc.
Microbiology · 204d
Cleared Jan 21, 1986
MYO-ACTUATOR
K852963 · HCC
Verimed Holdings, Inc.
Neurology · 193d