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
91033–91056 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 09, 1997
TORNIER CEMENT RESTRICTOR
K973453 · JDI
Tornier
General & Plastic Surgery · 89d
Cleared Dec 09, 1997
ELITE POWDER FREE POLYURETHANE SYNTHETIC SURGICAL GLOVE
K973461 · KGO
Ansell Perry
General Hospital · 88d
Cleared Dec 09, 1997
COHERENT POPEYE OPHTHALMIC LASER SYSTEM, COHERENT POPEYE OPHTHALMIC LASER...
K973470 · GEX
Lumenis, Inc.
General & Plastic Surgery · 88d
Cleared Dec 09, 1997
EPULSE MODEL 2940 ER:ASER ER:YAG LASER SYSTEM
K973576 · GEX
Epulse Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Dec 09, 1997
ORION MEDICAL INC. DISPOSABLE BRAIN BIOPSY NEEDLE FOR STEROTACTIC GUIDED BIOPSY
K974158 · KNW
Ortho Development Corp.
Gastroenterology & Urology · 36d
Cleared Dec 08, 1997
COBE OPTIMA XP HOLLOW FIBER MEMBRANE OXYGENATOR
K963518 · DTZ
Cobe Cardiovascular, Inc.
Cardiovascular · 461d
Cleared Dec 08, 1997
FREEDOM
K973089 · EBF
Southern Dental Industries, Inc.
Dental · 112d
Cleared Dec 08, 1997
WAVE
K973091 · EBF
Southern Dental Industries, Inc.
Dental · 112d
Cleared Dec 08, 1997
STAE
K973092 · KLE
Southern Dental Industries, Inc.
Dental · 112d
Cleared Dec 08, 1997
OSTEONICS SERIES 7000 TOTAL KNEE AUGMENTED FEMORAL COMPONENT
K973406 · JWH
Osteonics Corp.
Orthopedic · 90d
Cleared Dec 08, 1997
NATURAL-KNEE II CONSTRAINED KNEE SYSTEM
K973412 · JWH
Sulzer Orthopedics, Inc.
Orthopedic · 90d
Cleared Dec 08, 1997
ENDO ANALYZER, MODEL 8005
K973439 · EAT
Sybron Dental Specialties, Inc.
Dental · 89d
Cleared Dec 08, 1997
MODEL IRC 1199 SCOUT NEBULIZER
K973468 · CAF
Invacare Corp.
Anesthesiology · 87d
Cleared Dec 08, 1997
3M CDI H/S CUVETTES WITH HEPARON TREATMENT
K973472 · DRY
3M Healthcare
Cardiovascular · 87d
Cleared Dec 08, 1997
CLEARVIEW BLOWER/MISTER
K973485 · FQH
Dlp, Inc.
General Hospital · 84d
Cleared Dec 08, 1997
DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML)
K973510 · FMF
Immuno-U.S., Inc.
General Hospital · 83d
Cleared Dec 08, 1997
SUNGLASSES
K973528 · HQY
Jeou Jeou Long Industrial Co., Ltd.
Ophthalmic · 82d
Cleared Dec 08, 1997
SOWELL PATENTED NON-PRECIOUS METAL ALLOY
K973566 · EJH
C.K. International Trading
Dental · 80d
Cleared Dec 08, 1997
FRAG COMMANDER
K973749 · HQC
Scieran Technologies, Inc.
Ophthalmic · 68d
Cleared Dec 08, 1997
AL-47 TORIC (ISOFILCON) SOFT (TORIC) DAILY WEAR CONTACT LENS
K973847 · LPL
Martin Dalsing
Ophthalmic · 61d
Cleared Dec 08, 1997
AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR &...
K973967 · LPL
Alden Optical Labs., Inc.
Ophthalmic · 52d
Cleared Dec 08, 1997
RANDOX BILIRUBIN
K973995 · GIG
Randox Laboratories, Ltd.
Chemistry · 48d
Cleared Dec 08, 1997
AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10
K974053 · JFJ
Diagnostic Chemicals , Ltd.
Chemistry · 42d
Cleared Dec 08, 1997
CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN
K974325 · DDR
Chiron Diagnostics Corp.
Chemistry · 20d