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
132961–132984 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 16, 1988
TDX METHADONE ASSAY
K884968 · DJR
Abbott Laboratories
Toxicology · 16d
Cleared Dec 16, 1988
CHLAMYDIAZYME/COMMANDER INSTRUMENTATION
K885006 · LJC
Abbott Laboratories
Microbiology · 14d
Cleared Dec 15, 1988
EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN ANTIBODY TEST
K882440 · LLM
Zeus Scientific, Inc.
Microbiology · 184d
Cleared Dec 15, 1988
EPSTEIN-BARR VIRUS EARLY ANTIGEN (EA) ANTIBODY TES
K882447 · LSE
Zeus Scientific, Inc.
Microbiology · 184d
Cleared Dec 15, 1988
BIODOP(TM)
K883334 · HEK
Diagnosis Related Systems, Inc.
Obstetrics & Gynecology · 128d
Cleared Dec 15, 1988
ABC FP ANALYZER
K883533 · JJE
Intl. Bioclinical, Inc.
Chemistry · 119d
Cleared Dec 15, 1988
THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL
K883726 · JLW
Immuchem Corp.
Chemistry · 106d
Cleared Dec 15, 1988
UROIMAGER
K883925 · IYO
Ausonics Pty , Ltd.
Radiology · 90d
Cleared Dec 15, 1988
CENTURY COLOR TRACE
K884152 · DSI
Biomedical Systems, Inc.
Cardiovascular · 73d
Cleared Dec 15, 1988
TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS
K884224 · CIG
A-Kem, Inc.
Chemistry · 70d
Cleared Dec 15, 1988
IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436
K884278 · DTB
Telectronics, Inc.
Cardiovascular · 64d
Cleared Dec 15, 1988
MODIFIED JELTRODE(TM) ELECTRODES DEEMED
K884348 · GXY
Henley Intl.
Neurology · 62d
Cleared Dec 15, 1988
LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN)
K884424 · JJW
Bio-Rad
Chemistry · 56d
Cleared Dec 15, 1988
UNIVERSAL(TM) ION SELECT ELECTRODE STANDARDS
K884693 · JIX
Biomedical Research & Development...
Chemistry · 36d
Cleared Dec 15, 1988
JOHNSON & JOHNSON STERILE SPRAY TIP SYRINGE
K884749 · KYZ
Johnson & Johnson Patient Care, Inc.
General Hospital · 31d
Cleared Dec 15, 1988
ALLEN PRONE ARMBOARD
K884838 · BTX
Edgewater Medical Systems, Inc.
General & Plastic Surgery · 24d
Cleared Dec 15, 1988
S 4 INSTRUMENT STAND
K884876 · FSH
Carl Zeiss, Inc.
General & Plastic Surgery · 24d
Cleared Dec 15, 1988
FREE ARM(TM)
K884928 · FWZ
Faro Medical Technologies, Inc.
General & Plastic Surgery · 17d
Cleared Dec 15, 1988
OCCUSHIELDS
K884929 · FXX
Dioptics
General Hospital · 17d
Cleared Dec 15, 1988
SHARPLAN-MEDILAS 4060N YAG LASER & SERIES 2900 TIP
K884994 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 14d
Cleared Dec 14, 1988
SLT CONTACT LASER SYSTEM CYCLOPHOTOCOAGULATION
K882679 · HQB
Surgical Laser Technologies, Inc.
Ophthalmic · 169d
Cleared Dec 14, 1988
TAB PAK
K882731 · NXB
Dynex Trading Co.
General Hospital · 166d
Cleared Dec 14, 1988
WWDS-005 HUMAN RECTAL PROBE
K883079 · IYO
Ausonics Pty , Ltd.
Radiology · 146d
Cleared Dec 14, 1988
RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD
K883389 · JIW
Reagents Applications, Inc.
Chemistry · 126d