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
132457–132480 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 03, 1989
PARAMETRIUM CLAMP
K890381 · HXD
Kinetic Medical Products
General & Plastic Surgery · 11d
Cleared Feb 02, 1989
GLUCOSE-SUPER FAST 4983050 AND 4983500
K882262 · CGA
American Research Products Co.
Chemistry · 247d
Cleared Feb 02, 1989
SOURCERER
K884091 · JJJ
John Caunt Scientific , Ltd.
Toxicology · 127d
Cleared Feb 02, 1989
CREATINE KINASE TEST (CK) ITEM NUMBER: 65661
K884546 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 94d
Cleared Feb 02, 1989
ORTHO RESULT PLUS/RUBELLA RAPID COLOR. IMMUNOASSAY
K884617 · LFX
Ortho Diagnostic Systems, Inc.
Microbiology · 90d
Cleared Feb 02, 1989
PACH-PEN CALCULATOR
K884619 · DXG
Oculab, Inc.
Cardiovascular · 90d
Cleared Feb 02, 1989
PATIENT MONITOR RIGEL MODEL MULTICARE 429
K884645 · DRT
Rigel Medical Electronics, Inc.
Cardiovascular · 87d
Cleared Feb 02, 1989
PATIENT MONITOR MODEL 703
K884662 · DPS
Ivy Biomedical Systems, Inc.
Cardiovascular · 87d
Cleared Feb 02, 1989
ESCORT NON-INVASIVE BLOOD PRESSURE OPTION
K884742 · DXN
Medical Data Electronics
Cardiovascular · 80d
Cleared Feb 02, 1989
PROGESTERONE SEROZYME IMMUNOENZYMETRIC ASSAY
K884794 · JLS
Serono-Baker Diagnostics, Inc.
Chemistry · 78d
Cleared Feb 02, 1989
ACCESS(TM) MAGNETIC RESONANCE DEVICE ACCESSORY
K884816 · LNH
Diasonics, Inc.
Radiology · 77d
Cleared Feb 02, 1989
BASIC BIOFEEDBACK,TMG4.1, SA1/2, EEG4/5, IR RECEIV
K884848 · HCC
Moe
Neurology · 76d
Cleared Feb 02, 1989
BIOFEEDBACK TMG1, 4, BIO1, PA1, 2, BA1/BA30
K884850 · HCC
Moe
Neurology · 76d
Cleared Feb 02, 1989
BIOFEEDBACK DEVICE EMG1, EMG ULTRA LOW NOISE OPTI.
K884852 · HCC
Moe
Neurology · 76d
Cleared Feb 02, 1989
BIOFEEDBACK EEG1/2, EEG ULTRA LOW NOISE, SYC1
K884853 · HCC
Moe
Neurology · 76d
Cleared Feb 02, 1989
DADE PROTEIN C CHROMOGENIC ASSAY
K884881 · GGP
Baxter Healthcare Corp
Hematology · 72d
Cleared Feb 02, 1989
MODEL 250 LIQUID CHROMOTAGRAPHY PUMP
K884886 · LDM
The Perkin-Elmer Corp.
Chemistry · 72d
Cleared Feb 02, 1989
DADE(R) PROTOTROL SYNTHETIC SUBSTRATE ASSAY CONTRO
K884901 · GGN
Baxter Healthcare Corp
Hematology · 71d
Cleared Feb 02, 1989
T-UPTAKE MICROASSAY
K885034 · CEE
Diamedix Corp.
Chemistry · 59d
Cleared Feb 02, 1989
IMMUNODOT RUBELLA TEST
K885082 · LFX
General Biometrics, Inc.
Microbiology · 55d
Cleared Feb 02, 1989
CLINISTAT SGPT (ALT) SERUM GLUTAMATE PYRUVATE TRAN
K885144 · CKA
Heraeus Kulzer, Inc.
Chemistry · 49d
Cleared Feb 02, 1989
CLINISTAT SGOT (AST) REAGENT TEST
K885156 · CIT
Heraeus Kulzer, Inc.
Chemistry · 49d
Cleared Feb 02, 1989
VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE)
K890350 · DTB
Telectronics, Inc.
Cardiovascular · 86d
Cleared Feb 01, 1989
AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU.
K881857 · KXO
Spectramed, Inc.
Obstetrics & Gynecology · 274d