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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
112417–112440 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 05, 1993
MAICO MA790 AUDIOMETER
K930112 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 206d
Cleared Aug 05, 1993
CENTRICON -50 CONCENTRATOR
K930168 · JJH
Amicon, Inc.
Chemistry · 204d
Cleared Aug 05, 1993
BOEHRINGER MANNHEIM COAGUCHEK SYSTEM
K930454 · JPA
Boehringer Mannheim Corp.
Hematology · 190d
Cleared Aug 05, 1993
BENZODIAZEPINE ENZYME IMMUNOASSAY
K930529 · JXM
Diagnostic Reagents, Inc.
Toxicology · 184d
Cleared Aug 05, 1993
COBAS(R) CORE IGE TOTAL EIA
K930890 · DGC
Roche Diagnostic Systems, Inc.
Immunology · 164d
Cleared Aug 05, 1993
DIGOXIN TEST SYSTEM, KXT TX
K931123 · KXT
Syva Co.
Toxicology · 154d
Cleared Aug 05, 1993
MIST MICROSURGICAL MONOPOLAR SCISSORS
K931274 · GCJ
Minimally Invasive Surgical...
General & Plastic Surgery · 150d
Cleared Aug 05, 1993
MIST MICROSURGICAL MONOPOLAR FORCEPS
K931275 · GCJ
Minimally Invasive Surgical...
General & Plastic Surgery · 150d
Cleared Aug 05, 1993
ADVANCE MODEL UDS-ADV
K931574 · EXQ
Laborie Medical Technologies, Ltd.
Gastroenterology & Urology · 128d
Cleared Aug 05, 1993
VISTA FERRITIN ASSAY
K931576 · DBF
Syva Co.
Immunology · 128d
Cleared Aug 05, 1993
SPECTACLE FRAMES
K931648 · HQZ
Eye Care Centers of America, Inc.
Ophthalmic · 122d
Cleared Aug 05, 1993
ROTATOR
K932251 · DTR
Merit Medical Systems, Inc.
Cardiovascular · 87d
Cleared Aug 05, 1993
MODIFICATION TO GHAJAR GUIDE TWIST DRILL
K932402 · HBG
Neurodynamics, Inc.
Neurology · 106d
Cleared Aug 05, 1993
ANTI-SS-B/LA ANTIBODY TEST
K932419 · LLL
Helix Diagnostics, Inc.
Immunology · 79d
Cleared Aug 05, 1993
OTICON MF
K932670 · ESD
Oticon Corp.
Ear, Nose, Throat · 64d
Cleared Aug 05, 1993
C-EQUAL(CEDERS-EMORY QUANTITIVE ANALYSIS)
K932745 · KPS
Adac Laboratories
Radiology · 58d
Cleared Aug 05, 1993
QUANTEM (TM)
K932957 · IYX
GE Medical Systems
Radiology · 49d
Cleared Aug 05, 1993
QUANTA LITE MITOCHONDRIA M2 ELISA
K933180 · DGC
Inova Diagnostics, Inc.
Immunology · 36d
Cleared Aug 03, 1993
DISETRONIC DOLOMAT PUMP
K920063 · FRW
Disetronic Medical Systems
General Hospital · 574d
Cleared Aug 03, 1993
PERCOR STAT DL 9.5 FR 40CC INTRA-AORTIC BALLOON
K920427 · DSP
Datascope Corp.
Cardiovascular · 547d
Cleared Aug 03, 1993
ULTRAFLO RATESAVER PLUS INFUSION PUMP
K921050 · FRN
Clinical Systems, Inc.
General Hospital · 516d
Cleared Aug 03, 1993
IAB ANCHOR
K922103 · KMK
Datascope Corp.
General Hospital · 454d
Cleared Aug 03, 1993
OMNI ARTHROSCOPE
K922321 · HRX
Expanded Optics, Inc.
Orthopedic · 442d
Cleared Aug 03, 1993
BIO-PEN SRK II CALCULATOR
K922590 · LQB
Bio-Rad
Ophthalmic · 427d